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A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cabotegravir IR Formulation (reference)
Cabotegravir DT Formulation (test 1)
Cabotegravir DT Formulation (test 2)
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Bioavailability, Cabotegravir, Dispersible tablet, Food effect, Human immunodeficiency virus, Immediate release tablet

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF). Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram). Body weight greater than or equal to (>=) 50.0 kilograms (kg) (110 pounds [lbs]) for males and >= 45 kg (99 lbs) for females and Body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m2) (inclusive) at Screening. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a Women of non child bearing potential (WONCBP) OR Is a Women of child bearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of less than (<)1 percent (%) per year). A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention (i.e., Day-1 of each treatment Period) The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Capable of giving signed informed consent. Exclusion Criteria: History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. History of seizures, and participants are required to have been seizure free, off anti epileptic drugs for a minimum of 2 years and will only be considered for enrollment following discussion with the Medical Monitor Abnormal blood pressure as determined by the investigator. Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome. A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention. Known suspected active Coronavirus disease 2019 (COVID-19) infection OR contact with an individual with known COVID-19 , within 14 days of study enrollment Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. Any Grade 2 to 4 laboratory abnormality at screening, with Creatine Phosphokinase and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT abnormalities, will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A positive test result for drugs of abuse (including marijuana), alcohol, or tobacco (indicating active current smoking) at screening or before the first dose of study intervention. Unable to refrain from the use of prescription or non-prescription drugs as detailed in the protocol. Unwillingness to abstain from excessive consumption of any food or drink detailed in the protocol. Would not be able to accommodate the blood loss during participation in the study Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. Current enrollment or past participation in another investigational study as detailed in the protocol. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. - Current enrollment or past participation in this clinical study. Positive hepatitis B and/or C test result at screening or within 3 months prior to first dose of study intervention. Positive pre-study drug/alcohol screen, including Tetrahydrocannabinol Positive Human immunodeficiency virus (HIV) antibody test (4th generation assay required). Regular use of tobacco- or nicotine-containing products within 6 months prior to screening History of regular alcohol consumption within 6 months of the study, History of sensitivity, prior intolerance or hypersensitivity to any of the study interventions, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. Participant and/or his her family is part of sponsor, clinical site, third party personnel.

Sites / Locations

  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2)

CAB DT Formulation (Test 1)/CAB IR Formulation (reference)/CAB DT Formulation (test 2)

CAB DT Formulation (test 2)/CAB IR Formulation (reference)/CAB DT Formulation (test 1)

CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1)

CAB DT Formulation (test 1)/CAB DT Formulation (test 2)/CAB IR Formulation (reference)

CAB DT Formulation (test 2)/CAB DT Formulation (test 1)/CAB IR Formulation (reference)

Arm Description

Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment .

Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Outcomes

Primary Outcome Measures

Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) following administration of CAB DT after a high fat meal
Area under the concentration time curve from time zero (pre-dose) extrapolated to last time of quantifiable concentration (AUC[0-last]) following administration of CAB DT after a high fat meal
Maximum observed concentration (Cmax) following administration of CAB DT after a high fat meal
AUC(0-inf) following administration of CAB DT in fasted state
AUC(0-last) following administration of CAB DT in fasted state
Cmax following administration of CAB DT in fasted state
AUC(0-inf) following administration of CAB IR in fasted state
AUC(0-last) following administration of CAB IR in fasted state
Cmax following administration of CAB IR in fasted state

Secondary Outcome Measures

Apparent terminal phase half-life (T1/2) following administration of CAB DT
Lag time before observation of drug concentrations in sampled matrix (tlag) following administration of CAB DT
Time of occurrence of Cmax (Tmax) following administration of CAB DT
Area under the concentration time curve from time zero extrapolated to 72 hours post-dose AUC(0-72) following administration of CAB DT
Concentration at 24 hours post-dose (C24) of following administration of CAB DT
Apparent oral clearance (CL/F) following administration of CAB DT
Apparent volume of distribution (Vz/F) following administration of CAB DT
T1/2 following administration of CAB DT in fasted state
Tlag following administration of CAB DT in fasted state
Tmax following administration of CAB DT in fasted state
AUC(0-72) following administration of CAB DT in fasted state
C24 following administration of CAB DT in fasted state
CL/F following administration of CAB DT in fasted state
Vz/F following administration of CAB DT in fasted state
T1/2 following administration of CAB IR in fasted state
Tlag following administration of CAB IR in fasted state
Tmax following administration of CAB IR in fasted state
AUC(0-72) following administration of CAB IR in fasted state
C24 following administration of CAB IR in fasted state
CL/F following administration of CAB IR in fasted state
Vz/F following administration of CAB IR in fasted state
Number of participants with Non-Serious Adverse events (AEs) and Serious adverse events (SAEs)
Number of participants with AEs by severity
Change from Baseline in Vital sign parameter: Oral Temperature (Degrees Celsius)
Change from Baseline in Vital sign parameter: Pulse rate (Beats per minute)
Change from Baseline in Vital sign parameter: Respiratory rate (Breaths per minute)
Change from Baseline in Vital sign parameter: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
Change from Baseline in Electrocardiogram (ECG) parameters: PR Interval, QRS Interval, QT Interval, Corrected QT interval using the Fridericia formula (QTcF) (Milliseconds)
Number of participants with maximum toxicity grade increase from Baseline in hematology, chemistry and urinalysis parameters
Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter)
Change from Baseline in hematology parameter: Red Blood Cell Count (Trillion cells per liter)
Change from Baseline in hematology parameter: Hemoglobin (Grams per liter)
Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Change from Baseline in hematology parameter: Mean Corpuscular Volume (Femtoliters)
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (Picograms)
Change from Baseline in hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes)
Change from Baseline in chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter)
Change from Baseline in chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter)
Change from Baseline in chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine phosphokinase (International units per liter)
Change from Baseline in chemistry parameters: Total Protein (Grams per liter)
Number of participants with abnormal urinalysis parameters
Absolute values of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter)
Absolute values of hematology parameter: Red Blood Cell Count (Trillion cells per liter)
Absolute values of hematology parameter: Hemoglobin (Grams per liter)
Absolute values of hematology parameter: Hematocrit (Proportion of red blood cells in blood
Absolute values of hematology parameter: Mean Corpuscular Volume (Femtoliters)
Absolute values of hematology parameter: Mean Corpuscular Hemoglobin (Picograms)
Absolute values of hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes)
Absolute values of chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter)
Absolute values of chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter)
Absolute values of chemistry parameters: ALT, ALP, AST and Creatine phosphokinase (International units per liter)
Absolute values of chemistry parameters: Total Protein (Grams per liter)

Full Information

First Posted
March 8, 2023
Last Updated
April 20, 2023
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05776108
Brief Title
A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation
Official Title
A Phase 1, Single-center, Randomized, Open-label, Single Dose, Three-period, Balanced Crossover Study to Assess the Effect of Food on the Pediatric Dispersible Tablet Formulation of Cabotegravir and to Assess the Relative Bioavailability Between the Pediatric Dispersible Tablet (DT) Formulation and Immediate Release (IR) Tablet Formulation of Cabotegravir in Healthy Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
June 8, 2023 (Anticipated)
Study Completion Date
June 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Bioavailability, Cabotegravir, Dispersible tablet, Food effect, Human immunodeficiency virus, Immediate release tablet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
This is an open-label study
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2)
Arm Type
Experimental
Arm Description
Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment .
Arm Title
CAB DT Formulation (Test 1)/CAB IR Formulation (reference)/CAB DT Formulation (test 2)
Arm Type
Experimental
Arm Description
Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Arm Title
CAB DT Formulation (test 2)/CAB IR Formulation (reference)/CAB DT Formulation (test 1)
Arm Type
Experimental
Arm Description
Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Arm Title
CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1)
Arm Type
Experimental
Arm Description
Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Arm Title
CAB DT Formulation (test 1)/CAB DT Formulation (test 2)/CAB IR Formulation (reference)
Arm Type
Experimental
Arm Description
Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Arm Title
CAB DT Formulation (test 2)/CAB DT Formulation (test 1)/CAB IR Formulation (reference)
Arm Type
Experimental
Arm Description
Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.
Intervention Type
Drug
Intervention Name(s)
Cabotegravir IR Formulation (reference)
Intervention Description
Cabotegravir IR Formulation (reference) will be administered.
Intervention Type
Drug
Intervention Name(s)
Cabotegravir DT Formulation (test 1)
Intervention Description
Cabotegravir DT Formulation (test 1) will be administered.
Intervention Type
Drug
Intervention Name(s)
Cabotegravir DT Formulation (test 2)
Intervention Description
Cabotegravir DT Formulation (test 2) will be administered.
Primary Outcome Measure Information:
Title
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) following administration of CAB DT after a high fat meal
Time Frame
Up to 168 hours
Title
Area under the concentration time curve from time zero (pre-dose) extrapolated to last time of quantifiable concentration (AUC[0-last]) following administration of CAB DT after a high fat meal
Time Frame
Up to 168 hours
Title
Maximum observed concentration (Cmax) following administration of CAB DT after a high fat meal
Time Frame
Up to 168 hours
Title
AUC(0-inf) following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
AUC(0-last) following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
Cmax following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
AUC(0-inf) following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
AUC(0-last) following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
Cmax following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Secondary Outcome Measure Information:
Title
Apparent terminal phase half-life (T1/2) following administration of CAB DT
Time Frame
Up to 168 hours
Title
Lag time before observation of drug concentrations in sampled matrix (tlag) following administration of CAB DT
Time Frame
Up to 168 hours
Title
Time of occurrence of Cmax (Tmax) following administration of CAB DT
Time Frame
Up to 168 hours
Title
Area under the concentration time curve from time zero extrapolated to 72 hours post-dose AUC(0-72) following administration of CAB DT
Time Frame
Up to 72 Hours
Title
Concentration at 24 hours post-dose (C24) of following administration of CAB DT
Time Frame
At 24 Hours
Title
Apparent oral clearance (CL/F) following administration of CAB DT
Time Frame
Up to 168 hours
Title
Apparent volume of distribution (Vz/F) following administration of CAB DT
Time Frame
Up to 168 hours
Title
T1/2 following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
Tlag following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
Tmax following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
AUC(0-72) following administration of CAB DT in fasted state
Time Frame
Up to 72 Hours
Title
C24 following administration of CAB DT in fasted state
Time Frame
At 24 Hours
Title
CL/F following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
Vz/F following administration of CAB DT in fasted state
Time Frame
Up to 168 hours
Title
T1/2 following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
Tlag following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
Tmax following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
AUC(0-72) following administration of CAB IR in fasted state
Time Frame
Up to 72 Hours
Title
C24 following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
CL/F following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
Vz/F following administration of CAB IR in fasted state
Time Frame
Up to 168 hours
Title
Number of participants with Non-Serious Adverse events (AEs) and Serious adverse events (SAEs)
Time Frame
Up to 6 Weeks
Title
Number of participants with AEs by severity
Time Frame
Up to 6 Weeks
Title
Change from Baseline in Vital sign parameter: Oral Temperature (Degrees Celsius)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in Vital sign parameter: Pulse rate (Beats per minute)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in Vital sign parameter: Respiratory rate (Breaths per minute)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in Vital sign parameter: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in Electrocardiogram (ECG) parameters: PR Interval, QRS Interval, QT Interval, Corrected QT interval using the Fridericia formula (QTcF) (Milliseconds)
Time Frame
Baseline and Up to 6 Weeks
Title
Number of participants with maximum toxicity grade increase from Baseline in hematology, chemistry and urinalysis parameters
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in hematology parameter: Red Blood Cell Count (Trillion cells per liter)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in hematology parameter: Hemoglobin (Grams per liter)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in hematology parameter: Mean Corpuscular Volume (Femtoliters)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (Picograms)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine phosphokinase (International units per liter)
Time Frame
Baseline and Up to 6 Weeks
Title
Change from Baseline in chemistry parameters: Total Protein (Grams per liter)
Time Frame
Baseline and Up to 6 Weeks
Title
Number of participants with abnormal urinalysis parameters
Time Frame
Up to 6 Weeks
Title
Absolute values of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter)
Time Frame
Up to 6 Weeks
Title
Absolute values of hematology parameter: Red Blood Cell Count (Trillion cells per liter)
Time Frame
Up to 6 Weeks
Title
Absolute values of hematology parameter: Hemoglobin (Grams per liter)
Time Frame
Up to 6 Weeks
Title
Absolute values of hematology parameter: Hematocrit (Proportion of red blood cells in blood
Time Frame
Up to 6 Weeks
Title
Absolute values of hematology parameter: Mean Corpuscular Volume (Femtoliters)
Time Frame
Up to 6 Weeks
Title
Absolute values of hematology parameter: Mean Corpuscular Hemoglobin (Picograms)
Time Frame
Up to 6 Weeks
Title
Absolute values of hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes)
Time Frame
Up to 6 Weeks
Title
Absolute values of chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter)
Time Frame
Up to 6 Weeks
Title
Absolute values of chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter)
Time Frame
Up to 6 Weeks
Title
Absolute values of chemistry parameters: ALT, ALP, AST and Creatine phosphokinase (International units per liter)
Time Frame
Up to 6 Weeks
Title
Absolute values of chemistry parameters: Total Protein (Grams per liter)
Time Frame
Up to 6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF). Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram). Body weight greater than or equal to (>=) 50.0 kilograms (kg) (110 pounds [lbs]) for males and >= 45 kg (99 lbs) for females and Body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m2) (inclusive) at Screening. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a Women of non child bearing potential (WONCBP) OR Is a Women of child bearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of less than (<)1 percent (%) per year). A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention (i.e., Day-1 of each treatment Period) The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Capable of giving signed informed consent. Exclusion Criteria: History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. History of seizures, and participants are required to have been seizure free, off anti epileptic drugs for a minimum of 2 years and will only be considered for enrollment following discussion with the Medical Monitor Abnormal blood pressure as determined by the investigator. Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome. A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention. Known suspected active Coronavirus disease 2019 (COVID-19) infection OR contact with an individual with known COVID-19 , within 14 days of study enrollment Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. Any Grade 2 to 4 laboratory abnormality at screening, with Creatine Phosphokinase and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT abnormalities, will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A positive test result for drugs of abuse (including marijuana), alcohol, or tobacco (indicating active current smoking) at screening or before the first dose of study intervention. Unable to refrain from the use of prescription or non-prescription drugs as detailed in the protocol. Unwillingness to abstain from excessive consumption of any food or drink detailed in the protocol. Would not be able to accommodate the blood loss during participation in the study Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. Current enrollment or past participation in another investigational study as detailed in the protocol. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. - Current enrollment or past participation in this clinical study. Positive hepatitis B and/or C test result at screening or within 3 months prior to first dose of study intervention. Positive pre-study drug/alcohol screen, including Tetrahydrocannabinol Positive Human immunodeficiency virus (HIV) antibody test (4th generation assay required). Regular use of tobacco- or nicotine-containing products within 6 months prior to screening History of regular alcohol consumption within 6 months of the study, History of sensitivity, prior intolerance or hypersensitivity to any of the study interventions, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. Participant and/or his her family is part of sponsor, clinical site, third party personnel.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Brian Spears, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

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