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A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

Primary Purpose

HIV Infections

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cabotegravir Formulation F
Cabotegravir Formulation G
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 Cabotegravir, Pharmacokinetics

Eligibility Criteria

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

Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring Body weight =>40 kilogram (kg) and body mass index (BMI) within the range =>18 to =<32 kilogram per meter square (kg/m^2) Participants who are negative on a single test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(approved molecular polymerase chain reaction [PCR] laboratory or point of care test) performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% from the time of screening and inclusive of the entire time while on the study. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within the 30 days before the first dose of study intervention. Capable of giving written informed consent Exclusion Criteria: Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders. Current or chronic history of liver disease or known hepatic or biliary abnormalities. History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period. Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. Signs and symptoms which, in the opinion of the investigator, are suggestive of coronavirus disease 2019 (COVID-19) (e.g., fever, cough) within 14 days prior to screening; and/or contact with known COVID-19 positive person(s) in the 14 days prior to screening. Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test. History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use. Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Abnormal blood pressure. Evidence of previous myocardial infarction. Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [2nd degree or higher], Wolff- Parkinson-White [WPW] syndrome). Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant. One or more exclusionary values for a screening Electrocardiogram (ECG). Alanine transaminase (ALT) >1.5x upper limit of normal (ULN). Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]). Estimated Glomerular Filtration Rate (eGFR) <60 milliliter per minute (mL/min) using the Chronic Kidney Disease - Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021). Haemoglobin <12.5 gram per deciliter (g/dL) for men and <11 g/dL for women. Positive pre-study drug/alcohol screen. Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices). Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >14 units for males or >7 units for females. Regular use of known drugs of abuse. Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days. Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day. History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation Current or anticipated need for chronic anti-coagulation therapy (with the exception of low-dose aspirin =< 325 mg/day) Hereditary coagulation and platelet disorders (e.g., haemophilia or Von Willebrand disease [VWD]). Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention. Any other clinical condition, behaviour or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: Participants receiving Cabotegravir Formulation F

Part B: Participants receiving Cabotegravir Formulation G

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) of cabotegravir
Time of maximum observed plasma concentration (tmax) of cabotegravir
Area under the concentration - time curve from time zero to 4 weeks following the injection (AUC[0-4]) of cabotegravir
Plasma Concentration of cabotegravir at Week 4
Number of participants with adverse events (AEs) based on severity
Absolute value of haematology parameter: Platelet count (cells per microliter)
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre)
Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood)
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes)
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed.
Absolute values of Clinical chemistry parameters: Total Protein (Grams per deciliter)
Absolute values of Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR2) (millilitres per minute)
Change from Baseline in haematology parameter: Platelet count (cells per microliter)
Change from Baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes)
Change from baseline in haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Change from baseline in Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Change from baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Change from baseline in Clinical chemistry parameters: Total Protein (Grams per deciliter)
Change from baseline in Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR) (millilitres per minute)

Secondary Outcome Measures

Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir
Area under the concentration - time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of cabotegravir
Plasma Concentration of cabotegravir at Week 8,12 and 24
Apparent terminal phase half-life (t1/2) of cabotegravir
Apparent long-acting absorption rate constant (KA-LA) of cabotegravir
Dose proportionality of cabotegravir based on AUC(0-inf), AUC(0-last), Cmax, and plasma concentration (Unit of measure: Slope of log dose)
Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec)
Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec)
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline will be categorized into change to low, change to within range or no change, and change to high

Full Information

First Posted
August 31, 2023
Last Updated
September 4, 2023
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT06033547
Brief Title
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants
Official Title
A Phase I, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Two Different Formulations of Long-acting Cabotegravir Administered to Healthy Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 11, 2023 (Anticipated)
Primary Completion Date
February 19, 2025 (Anticipated)
Study Completion Date
February 19, 2025 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants. The study will initially start with the assessment of Cabotegravir Formulation F. Once the clinical batch of Cabotegravir Formulation G is available and depending on data for Formulation F, this formulation will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Cabotegravir, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Participants receiving Cabotegravir Formulation F
Arm Type
Experimental
Arm Title
Part B: Participants receiving Cabotegravir Formulation G
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cabotegravir Formulation F
Intervention Description
Cabotegravir Formulation F will be administered
Intervention Type
Drug
Intervention Name(s)
Cabotegravir Formulation G
Intervention Description
Cabotegravir Formulation G will be administered
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of cabotegravir
Time Frame
Up to Week 52
Title
Time of maximum observed plasma concentration (tmax) of cabotegravir
Time Frame
Up to Week 52
Title
Area under the concentration - time curve from time zero to 4 weeks following the injection (AUC[0-4]) of cabotegravir
Time Frame
Up to Week 4
Title
Plasma Concentration of cabotegravir at Week 4
Time Frame
Week 4
Title
Number of participants with adverse events (AEs) based on severity
Time Frame
Up to Week 52
Title
Absolute value of haematology parameter: Platelet count (cells per microliter)
Time Frame
Up to Week 52
Title
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Time Frame
Up to Week 52
Title
Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre)
Time Frame
Up to Week 52
Title
Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood)
Time Frame
Up to Week 52
Title
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Time Frame
Up to Week 52
Title
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Time Frame
Up to Week 52
Title
Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes)
Time Frame
Up to Week 52
Title
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time Frame
Up to Week 52
Title
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Time Frame
Up to Week 52
Title
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Description
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed.
Time Frame
Up to Week 52
Title
Absolute values of Clinical chemistry parameters: Total Protein (Grams per deciliter)
Time Frame
Up to Week 52
Title
Absolute values of Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR2) (millilitres per minute)
Time Frame
Up to Week 52
Title
Change from Baseline in haematology parameter: Platelet count (cells per microliter)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from Baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Description
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in Clinical chemistry parameters: Total Protein (Grams per deciliter)
Time Frame
Baseline (Day 1) and up to Week 52
Title
Change from baseline in Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR) (millilitres per minute)
Time Frame
Baseline (Day 1) and up to Week 52
Secondary Outcome Measure Information:
Title
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir
Time Frame
Up to Week 52
Title
Area under the concentration - time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of cabotegravir
Time Frame
Up to Week 52
Title
Plasma Concentration of cabotegravir at Week 8,12 and 24
Time Frame
Week 8, 12 and 24
Title
Apparent terminal phase half-life (t1/2) of cabotegravir
Time Frame
Up to Week 52
Title
Apparent long-acting absorption rate constant (KA-LA) of cabotegravir
Time Frame
Up to Week 52
Title
Dose proportionality of cabotegravir based on AUC(0-inf), AUC(0-last), Cmax, and plasma concentration (Unit of measure: Slope of log dose)
Time Frame
Up to Week 52
Title
Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec)
Time Frame
Up to Week 52
Title
Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec)
Time Frame
Up to Week 52
Title
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate
Description
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline will be categorized into change to low, change to within range or no change, and change to high
Time Frame
Up to Week 52

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: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring Body weight =>40 kilogram (kg) and body mass index (BMI) within the range =>18 to =<32 kilogram per meter square (kg/m^2) Participants who are negative on a single test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(approved molecular polymerase chain reaction [PCR] laboratory or point of care test) performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% from the time of screening and inclusive of the entire time while on the study. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within the 30 days before the first dose of study intervention. Capable of giving written informed consent Exclusion Criteria: Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders. Current or chronic history of liver disease or known hepatic or biliary abnormalities. History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period. Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. Signs and symptoms which, in the opinion of the investigator, are suggestive of coronavirus disease 2019 (COVID-19) (e.g., fever, cough) within 14 days prior to screening; and/or contact with known COVID-19 positive person(s) in the 14 days prior to screening. Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test. History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use. Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Abnormal blood pressure. Evidence of previous myocardial infarction. Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [2nd degree or higher], Wolff- Parkinson-White [WPW] syndrome). Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant. One or more exclusionary values for a screening Electrocardiogram (ECG). Alanine transaminase (ALT) >1.5x upper limit of normal (ULN). Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]). Estimated Glomerular Filtration Rate (eGFR) <60 milliliter per minute (mL/min) using the Chronic Kidney Disease - Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021). Haemoglobin <12.5 gram per deciliter (g/dL) for men and <11 g/dL for women. Positive pre-study drug/alcohol screen. Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices). Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >14 units for males or >7 units for females. Regular use of known drugs of abuse. Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days. Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day. History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation Current or anticipated need for chronic anti-coagulation therapy (with the exception of low-dose aspirin =< 325 mg/day) Hereditary coagulation and platelet disorders (e.g., haemophilia or Von Willebrand disease [VWD]). Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention. Any other clinical condition, behaviour or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
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
Facility Information:
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
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
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com

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 Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

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