Back to resultsA Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK3640254
DTG
GSK3640254/DTG
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Dolutegravir, GSK3640254, Fixed Dose Combinations, Bioavailability
Eligibility Criteria
Inclusion Criteria:
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
- Participants capable of giving signed informed consent.
Exclusion Criteria:
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A pre-existing condition interfering with normal gastro intestinal anatomy or motility (for example [e.g.], gastroesophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.
- Prior cholecystectomy surgery (prior appendectomy is acceptable).
- Clinically significant illness, including viral syndromes within 3 weeks of dosing.
- Participant with known or suspected active Coronavirus disease (COVID)-19 infection or contact with an individual with known COVID-19, within 14 days of study enrollment.
- Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research.
- Prior exposure to GSK3640254 or prior intolerance to DTG in this or another clinical study.
- Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).
- Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety for the individual participant.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1 : Treatment sequence ABC
Part 1 : Treatment sequence BCA
Part 1 : Treatment sequence CAB
Part 2 : Treatment sequence DE
Part 2 : Treatment sequence ED
Arm Description
Participants will receive a single oral dose of GSK3640254 25 milligrams (mg) (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 1, followed by a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 2. In Period 3, participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C).
Participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 1, followed by a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A).
Participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in period 1, followed by a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B).
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 2.
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 2.
Outcomes
Primary Outcome Measures
Parts 1 and 2: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]) for GSK3640254 and DTG
Parts 1 and 2: Area under the plasma concentration-time curve from time 0 to time t (AUC[0-t]) for GSK3640254 and DTG
Parts 1 and 2: Maximum observed concentration (Cmax) for GSK3640254 and DTG
Secondary Outcome Measures
Parts 1 and 2: Number of participants with adverse events (AEs) and Serious adverse events (SAEs)
Parts 1 and 2: Absolute values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, absolute neutrophil count and platelet count (Giga cells per liter)
Parts 1 and 2: Absolute values of Hematology Parameter: Hemoglobin (Grams per Liter)
Parts 1 and 2: Absolute values of Hematology Parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Parts 1 and 2: Absolute values of Hematology Parameter: Red blood cell count (RBC) count (Trillion cells per liter)
Parts 1 and 2: Absolute values of Hematology Parameter: Hematocrit (Proportion of red blood cells in blood)
Parts 1 and 2: Absolute values of Hematology Parameter: Mean corpuscular hemoglobin (picograms)
Parts 1 and 2: Change from Baseline in hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Absolute neutrophil count and platelet count (Giga cells per liter)
Parts 1 and 2: Change from Baseline in hematology Parameter: Hemoglobin (Grams per Liter)
Parts 1 and 2: Change from Baseline in hematology Parameter: MCV (Femtoliters)
Parts 1 and 2: Change from Baseline in hematology Parameter: RBC count (Trillion cells per liter)
Parts 1 and 2: Change from Baseline in Hematology Parameter: Hematocrit (Proportion of red blood cells in blood)
Parts 1 and 2: Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (picograms)
Parts 1 and 2 Absolute values for Alanine Amino Transferase (ALT),Alkaline Phosphatase (ALP),Aspartate Amino Transferase (AST),Gamma Glutamyl Transferase (GGT),Lactate dehydrogenase, Creatinine phosphokinase(International units per Liter)
Parts 1 and 2: Absolute values of clinical chemistry parameters: Calcium, carbon-dioxide (CO2), chloride, glucose, potassium, sodium, Blood urea nitrogen, phosphorus, Triglycerides, total cholesterol, and Anion gap (Millimole per Liter)
Parts 1 and 2: Absolute values of clinical chemistry parameters: Serum lipase, serum amylase (Units per Liter)
Parts 1 and 2: Absolute values of clinical chemistry parameters: Albumin, Globulin and Total protein (grams per liter)
Parts 1 and 2: Absolute values of clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (micromoles per liter)
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: ALT, ALP, AST, GGT, Lactate dehydrogenase, Creatinine phosphokinase (International units per Liter)
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Calcium, CO2, chloride, glucose, potassium, sodium, Blood urea nitrogen, phosphorus, Triglycerides, total cholesterol, and Anion gap (Millimoles per Liter)
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Serum lipase, serum amylase (Units per Liter)
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Albumin, Globulin and Total protein (grams per liter)
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (micromoles per liter)
Parts 1 and 2: Absolute values of Urinalysis parameter: Urine Specific Gravity
Parts 1 and 2: Absolute values of Urinalysis parameter: Urine potential of hydrogen (pH)
Parts 1 and 2: Absolute values of Urinalysis parameter: Glucose
Part 1 and 2: Absolute values of Urinalysis parameter: Protein
Part 1 and 2: Absolute values of Urinalysis parameter: Blood
Part 1 and 2: Absolute values of Urinalysis parameter: Ketones
Part 1 and 2: Absolute values of Urinalysis parameters: Bilirubin, Nitrite (Milligrams per deciliter)
Parts 1 and 2: Absolute values of Urinalysis parameter: Leukocyte esterase
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Urine Specific Gravity
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Urine pH
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Glucose
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Protein
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Blood
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Ketones
Parts 1 and 2: Change from Baseline in Urinalysis parameters: Bilirubin, Nitrite (Milligrams per deciliter)
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Leukocyte esterase
Parts 1 and 2: Absolute values of Electrocardiogram (ECG) parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) (milliseconds)
Parts 1 and 2: Change from Baseline in ECG parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval (milliseconds)
Parts 1 and 2:Absolute values of vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (millimeters of mercury)
Parts 1 and 2: Absolute values of vital signs: Pulse rate
Parts 1 and 2: Absolute values of vital signs: Temperature
Parts 1 and 2: Absolute values of vital signs : Respiratory rate
Parts 1 and 2: Change from Baseline in vital signs: DBP and SBP (millimeters of mercury)
Parts 1 and 2: Change from Baseline in vital signs : Pulse rate
Parts 1 and 2: Change from Baseline in vital signs: Temperature
Parts 1 and 2: Change from Baseline in vital signs: Respiratory rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04857892
Brief Title
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
Official Title
A Two-Part, Randomized, Open-Label, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Fixed-Dose Combinations of GSK3640254 and Dolutegravir and to Assess the Effect of Food on the Select Fixed Dose Combination of GSK3640254 and Dolutegravir in Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)
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 is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected FDC of GSK3640254/DTG (Part 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Dolutegravir, GSK3640254, Fixed Dose Combinations, Bioavailability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
This is a 2-part crossover study.
Masking
None (Open Label)
Masking Description
This is an open-label study
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 : Treatment sequence ABC
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of GSK3640254 25 milligrams (mg) (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 1, followed by a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 2. In Period 3, participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C).
Arm Title
Part 1 : Treatment sequence BCA
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 1, followed by a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A).
Arm Title
Part 1 : Treatment sequence CAB
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in period 1, followed by a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B).
Arm Title
Part 2 : Treatment sequence DE
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 2.
Arm Title
Part 2 : Treatment sequence ED
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 2.
Intervention Type
Drug
Intervention Name(s)
GSK3640254
Intervention Description
GSK3640254 will be administered via oral route.
Intervention Type
Drug
Intervention Name(s)
DTG
Intervention Description
DTG will be administered via oral route.
Intervention Type
Drug
Intervention Name(s)
GSK3640254/DTG
Intervention Description
GSK3640254/DTG will be administered via oral route.
Primary Outcome Measure Information:
Title
Parts 1 and 2: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]) for GSK3640254 and DTG
Time Frame
Up to Day 31
Title
Parts 1 and 2: Area under the plasma concentration-time curve from time 0 to time t (AUC[0-t]) for GSK3640254 and DTG
Time Frame
Up to Day 31
Title
Parts 1 and 2: Maximum observed concentration (Cmax) for GSK3640254 and DTG
Time Frame
Up to Day 31
Secondary Outcome Measure Information:
Title
Parts 1 and 2: Number of participants with adverse events (AEs) and Serious adverse events (SAEs)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, absolute neutrophil count and platelet count (Giga cells per liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Hematology Parameter: Hemoglobin (Grams per Liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Hematology Parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Hematology Parameter: Red blood cell count (RBC) count (Trillion cells per liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Hematology Parameter: Hematocrit (Proportion of red blood cells in blood)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Hematology Parameter: Mean corpuscular hemoglobin (picograms)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Change from Baseline in hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Absolute neutrophil count and platelet count (Giga cells per liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in hematology Parameter: Hemoglobin (Grams per Liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in hematology Parameter: MCV (Femtoliters)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in hematology Parameter: RBC count (Trillion cells per liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Hematology Parameter: Hematocrit (Proportion of red blood cells in blood)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (picograms)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2 Absolute values for Alanine Amino Transferase (ALT),Alkaline Phosphatase (ALP),Aspartate Amino Transferase (AST),Gamma Glutamyl Transferase (GGT),Lactate dehydrogenase, Creatinine phosphokinase(International units per Liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of clinical chemistry parameters: Calcium, carbon-dioxide (CO2), chloride, glucose, potassium, sodium, Blood urea nitrogen, phosphorus, Triglycerides, total cholesterol, and Anion gap (Millimole per Liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of clinical chemistry parameters: Serum lipase, serum amylase (Units per Liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of clinical chemistry parameters: Albumin, Globulin and Total protein (grams per liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (micromoles per liter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: ALT, ALP, AST, GGT, Lactate dehydrogenase, Creatinine phosphokinase (International units per Liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Calcium, CO2, chloride, glucose, potassium, sodium, Blood urea nitrogen, phosphorus, Triglycerides, total cholesterol, and Anion gap (Millimoles per Liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Serum lipase, serum amylase (Units per Liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Albumin, Globulin and Total protein (grams per liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (micromoles per liter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Absolute values of Urinalysis parameter: Urine Specific Gravity
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Urinalysis parameter: Urine potential of hydrogen (pH)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Urinalysis parameter: Glucose
Time Frame
Up to Day 31
Title
Part 1 and 2: Absolute values of Urinalysis parameter: Protein
Time Frame
Up to Day 31
Title
Part 1 and 2: Absolute values of Urinalysis parameter: Blood
Time Frame
Up to Day 31
Title
Part 1 and 2: Absolute values of Urinalysis parameter: Ketones
Time Frame
Up to Day 31
Title
Part 1 and 2: Absolute values of Urinalysis parameters: Bilirubin, Nitrite (Milligrams per deciliter)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of Urinalysis parameter: Leukocyte esterase
Time Frame
Up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Urine Specific Gravity
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Urine pH
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Glucose
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Protein
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Blood
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Ketones
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameters: Bilirubin, Nitrite (Milligrams per deciliter)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in Urinalysis parameter: Leukocyte esterase
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Absolute values of Electrocardiogram (ECG) parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) (milliseconds)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Change from Baseline in ECG parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval (milliseconds)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2:Absolute values of vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (millimeters of mercury)
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of vital signs: Pulse rate
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of vital signs: Temperature
Time Frame
Up to Day 31
Title
Parts 1 and 2: Absolute values of vital signs : Respiratory rate
Time Frame
Up to Day 31
Title
Parts 1 and 2: Change from Baseline in vital signs: DBP and SBP (millimeters of mercury)
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in vital signs : Pulse rate
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in vital signs: Temperature
Time Frame
Baseline and up to Day 31
Title
Parts 1 and 2: Change from Baseline in vital signs: Respiratory rate
Time Frame
Baseline and up to Day 31
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
Participants capable of giving signed informed consent.
Exclusion Criteria:
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
A pre-existing condition interfering with normal gastro intestinal anatomy or motility (for example [e.g.], gastroesophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.
Prior cholecystectomy surgery (prior appendectomy is acceptable).
Clinically significant illness, including viral syndromes within 3 weeks of dosing.
Participant with known or suspected active Coronavirus disease (COVID)-19 infection or contact with an individual with known COVID-19, within 14 days of study enrollment.
Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research.
Prior exposure to GSK3640254 or prior intolerance to DTG in this or another clinical study.
Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).
Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety for the individual participant.
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Learn more about this trial
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
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