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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2) | Experimental | 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 . |
|
| CAB DT Formulation (Test 1)/CAB IR Formulation (reference)/CAB DT Formulation (test 2) | Experimental | 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. |
|
| CAB DT Formulation (test 2)/CAB IR Formulation (reference)/CAB DT Formulation (test 1) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabotegravir IR Formulation (reference) | Drug | Cabotegravir IR Formulation (reference) will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 168 hours | |
| 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 | Up to 168 hours | |
| Maximum observed concentration (Cmax) following administration of CAB DT after a high fat meal | Up to 168 hours | |
| AUC(0-inf) following administration of CAB DT in fasted state | Up to 168 hours | |
| AUC(0-last) following administration of CAB DT in fasted state | Up to 168 hours | |
| Cmax following administration of CAB DT in fasted state | Up to 168 hours | |
| AUC(0-inf) following administration of CAB IR in fasted state | Up to 168 hours | |
| AUC(0-last) following administration of CAB IR in fasted state | Up to 168 hours | |
| Cmax following administration of CAB IR in fasted state | Up to 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent terminal phase half-life (T1/2) following administration of CAB DT | Up to 168 hours | |
| Lag time before observation of drug concentrations in sampled matrix (tlag) following administration of CAB DT | Up to 168 hours |
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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.
Capable of giving signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
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/
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.
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.
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This is an open-label study
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| CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1) | Experimental | 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. |
|
| CAB DT Formulation (test 1)/CAB DT Formulation (test 2)/CAB IR Formulation (reference) | Experimental | 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. |
|
| CAB DT Formulation (test 2)/CAB DT Formulation (test 1)/CAB IR Formulation (reference) | Experimental | 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. |
|
| Cabotegravir DT Formulation (test 1) | Drug | Cabotegravir DT Formulation (test 1) will be administered. |
|
| Cabotegravir DT Formulation (test 2) | Drug | Cabotegravir DT Formulation (test 2) will be administered. |
|
| Time of occurrence of Cmax (Tmax) following administration of CAB DT | Up to 168 hours |
| Area under the concentration time curve from time zero extrapolated to 72 hours post-dose AUC(0-72) following administration of CAB DT | Up to 72 Hours |
| Concentration at 24 hours post-dose (C24) of following administration of CAB DT | At 24 Hours |
| Apparent oral clearance (CL/F) following administration of CAB DT | Up to 168 hours |
| Apparent volume of distribution (Vz/F) following administration of CAB DT | Up to 168 hours |
| T1/2 following administration of CAB DT in fasted state | Up to 168 hours |
| Tlag following administration of CAB DT in fasted state | Up to 168 hours |
| Tmax following administration of CAB DT in fasted state | Up to 168 hours |
| AUC(0-72) following administration of CAB DT in fasted state | Up to 72 Hours |
| C24 following administration of CAB DT in fasted state | At 24 Hours |
| CL/F following administration of CAB DT in fasted state | Up to 168 hours |
| Vz/F following administration of CAB DT in fasted state | Up to 168 hours |
| T1/2 following administration of CAB IR in fasted state | Up to 168 hours |
| Tlag following administration of CAB IR in fasted state | Up to 168 hours |
| Tmax following administration of CAB IR in fasted state | Up to 168 hours |
| AUC(0-72) following administration of CAB IR in fasted state | Up to 72 Hours |
| C24 following administration of CAB IR in fasted state | Up to 168 hours |
| CL/F following administration of CAB IR in fasted state | Up to 168 hours |
| Vz/F following administration of CAB IR in fasted state | Up to 168 hours |
| Number of participants with Non-Serious Adverse events (AEs) and Serious adverse events (SAEs) | Up to 6 Weeks |
| Number of participants with AEs by severity | Up to 6 Weeks |
| Change from Baseline in Vital sign parameter: Oral Temperature (Degrees Celsius) | Baseline and Up to 6 Weeks |
| Change from Baseline in Vital sign parameter: Pulse rate (Beats per minute) | Baseline and Up to 6 Weeks |
| Change from Baseline in Vital sign parameter: Respiratory rate (Breaths per minute) | Baseline and Up to 6 Weeks |
| Change from Baseline in Vital sign parameter: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury) | Baseline and Up to 6 Weeks |
| Change from Baseline in Electrocardiogram (ECG) parameters: PR Interval, QRS Interval, QT Interval, Corrected QT interval using the Fridericia formula (QTcF) (Milliseconds) | Baseline and Up to 6 Weeks |
| Number of participants with maximum toxicity grade increase from Baseline in hematology, chemistry and urinalysis parameters | Baseline and Up to 6 Weeks |
| Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter) | Baseline and Up to 6 Weeks |
| Change from Baseline in hematology parameter: Red Blood Cell Count (Trillion cells per liter) | Baseline and Up to 6 Weeks |
| Change from Baseline in hematology parameter: Hemoglobin (Grams per liter) | Baseline and Up to 6 Weeks |
| Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood) | Baseline and Up to 6 Weeks |
| Change from Baseline in hematology parameter: Mean Corpuscular Volume (Femtoliters) | Baseline and Up to 6 Weeks |
| Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (Picograms) | Baseline and Up to 6 Weeks |
| Change from Baseline in hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes) | Baseline and Up to 6 Weeks |
| Change from Baseline in chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter) | Baseline and Up to 6 Weeks |
| Change from Baseline in chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter) | Baseline and Up to 6 Weeks |
| Change from Baseline in chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine phosphokinase (International units per liter) | Baseline and Up to 6 Weeks |
| Change from Baseline in chemistry parameters: Total Protein (Grams per liter) | Baseline and Up to 6 Weeks |
| Number of participants with abnormal urinalysis parameters | Up to 6 Weeks |
| Absolute values of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter) | Up to 6 Weeks |
| Absolute values of hematology parameter: Red Blood Cell Count (Trillion cells per liter) | Up to 6 Weeks |
| Absolute values of hematology parameter: Hemoglobin (Grams per liter) | Up to 6 Weeks |
| Absolute values of hematology parameter: Hematocrit (Proportion of red blood cells in blood | Up to 6 Weeks |
| Absolute values of hematology parameter: Mean Corpuscular Volume (Femtoliters) | Up to 6 Weeks |
| Absolute values of hematology parameter: Mean Corpuscular Hemoglobin (Picograms) | Up to 6 Weeks |
| Absolute values of hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes) | Up to 6 Weeks |
| Absolute values of chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter) | Up to 6 Weeks |
| Absolute values of chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter) | Up to 6 Weeks |
| Absolute values of chemistry parameters: ALT, ALP, AST and Creatine phosphokinase (International units per liter) | Up to 6 Weeks |
| Absolute values of chemistry parameters: Total Protein (Grams per liter) | Up to 6 Weeks |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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