Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1265744 · 4 trials · 4 indications
Plasma PK samples (2 mL of blood per sample) will be collected to measure GSK1265744 at the following time points: pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose
Plasma PK samples (2 mL of blood per sample) will be collected to measure GSK1265744 at the following time points: pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose
Plasma GSK1265744 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time \[AUC(0-infinity)\], Area under the concentration-time curve over the dosing interval \[AUC(0-t)\], and Maximum observed concentration (Cmax).
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1 (Moderate hepatic impairment subjects) | EXPERIMENTAL | Subjects with moderate hepatic impairment will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma |
| Part 1 Cohort 2 (Healthy control subjects) | EXPERIMENTAL | Healthy control subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma |
| Part 2 Cohort 3 (Mild hepatic impairment subjects) | EXPERIMENTAL | Subjects with mild hepatic impairment will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma |
| Part 2 Cohort 4 (Healthy control subjects) | EXPERIMENTAL | Healthy control subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma |
| Cohort 1 | EXPERIMENTAL | All subjects |
| Treatment A | EXPERIMENTAL | GSK1265744 10mg oral solution |
| Treatment B | EXPERIMENTAL | GSK1265744 5mg tablet, fasted |
| Treatment C | EXPERIMENTAL | GSK1265744 5mg tablet, fed |
| Name | Type | Description |
|---|---|---|
| GSK1265744 30mg | DRUG | GSK1265744 30mg tablets are white to almost white coated oval tablets. All subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by PK sampling. |
| GSK1265744 | DRUG | GSK drug |
| GSK1265744 10 mg oral solution | DRUG | GSK1265744 |
| GSK1265744 5 mg tablet | DRUG | GSK1265744 5mg tablet, fasted |
Inclusion Criteria: * Hepatic Impaired Subjects (Cohort 1 and 3) * Between 18 and 70 years of age Part 1 subjects with Moderate Hepatic Impairment Only (Cohort 1): * Subject is considered to have moderate hepatic impairment (of any etiology) and has been clinically stable for at least 1 month pri...
Top 20 of 28 competitors
GSK1265744 is an investigational small molecule being studied for HIV infections, including in healthy subjects and people with human immunodeficiency virus infection. It is in Phase 1 clinical development for infectious disease. The drug is not approved and remains under investigation in clinical trials.
GSK1265744 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy adult subjects.
GSK1265744 is in Phase 1 clinical development. All seven clinical trials for the drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved for any use.
GSK1265744 has been studied in seven completed Phase 1 trials, including NCT01593046, NCT01754116, NCT02027454, and NCT02059031. These trials evaluated repeat dosing, new formulations, cardiac conduction effects, and tablet bioavailability in healthy adult subjects with HIV infection.
GSK1265744 is also known as cabotegravir, an investigational integrase inhibitor being developed for HIV treatment and prevention. The drug is being studied in long-acting injectable formulations for potential use in HIV infection management.