Approval Probability
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Adjusted LOA
ML Risk
GSK1265744B · 1 trial · 1 indication
Measurement of total radioactivity present in individual samples (plasma, urine, and feces) collected for a minimum of 336 hours (14 days) post dose up to a maximum of 504 hours (21 days).
The PK parameters will include: Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a profile \[AUC (0-t)\], Area under the concentration-time curve from time zero (predose) extrapolated to infinite time \[AUC (0-infinity)\], Maximum observed concentration (Cmax), Time of occurrence of Cmax (tmax), Terminal phase elimination rate constant (lambda z), apparent terminal phase half-life (t1/2), and oral clearance (CL/F) of plasma GSK1265744 and total radioactivity in plasma and blood following single dose.
Plasma GSK1265744PK parameters following a single-dose administration of 150 mg under fasted conditions will include: AUC (0-t)\], AUC (0-infinity), Cmax, tmax, lambda z, t1/2, and oral clearance (CL/F) of plasma
| Arm | Type | Description |
|---|---|---|
| Part A: 14C-GSK1265744 Arm | EXPERIMENTAL | Each subject will receive a single 30 mg oral solution dose of GSK1265744 containing 14C-GSK1265744 of approximately 70 mcgCi (0.96 MSv) of radioactivity. |
| Part B: GSK1265744 Arm | EXPERIMENTAL | In Part B - 8 subjects will be randomised to receive a single dose of GSK1265744 150 mg |
| Part B: Placebo Arm | PLACEBO_COMPARATOR | In Part B - 2 subjects will be randomised to receive a single dose of placebo |
| Name | Type | Description |
|---|---|---|
| GSK1265744B (sodium salt) containing 14C-GSK1265744B | DRUG | A white to slightly colored nonsterile crystalline powder for oral solution |
| 150 mg GSK1265744B | DRUG | This is GSK1265744B (sodium salt of GSK1265744), lactose monohydrate, Microcrystalline cellulose, hypromellose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, Opadry film-coating, white OY-S-28876 tablet |
| Placebo | DRUG | Microcrystalline cellulose, Opadry film-coating, white OY-S-28876 tablet |
Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Part A: Male subjects between 30 and 55 years of age at the time of signing the informed consent. * Part ...
GSK1265744B is an investigational small molecule being studied for HIV-associated Lipodystrophy Syndrome, a condition related to fat redistribution in people with HIV. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
GSK1265744B is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The drug is currently in early-stage clinical research.
GSK1265744B is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for any use. One Phase 1 study has been completed, and the drug remains under evaluation for HIV-associated Lipodystrophy Syndrome.
GSK1265744B has one completed clinical trial, NCT01848340, which investigated the recovery, excretion, and pharmacokinetics of a related compound, GSK1265744, after a single oral dose, as well as the pharmacokinetics of a supratherapeutic dose in healthy adults. The study enrolled 16 participants in the United States.
GSK1265744B is the drug name used in this context, while the clinical trial NCT01848340 studied GSK1265744. The relationship between these two names is not specified, but the trial was designed to evaluate the pharmacokinetics of GSK1265744 in healthy volunteers.
The completed Phase 1 trial for GSK1265744B, NCT01848340, was a randomized, double-blind, placebo-controlled study. It enrolled 16 healthy adult participants in the United States and was designed to assess drug recovery, excretion, and pharmacokinetics.