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Also known as GSK1265744B (sodium salt) containing 14C-GSK1265744B
GSK1265744B containing 14C-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 containing 14C-GSK1265744B is a radiolabeled small molecule developed by GSK plc for HIV-associated lipodystrophy syndrome. The carbon-14 label allows researchers to track how the drug is absorbed, distributed, metabolized, and excreted in the body. It is an investigational agent in Phase 1 testing.
GSK1265744B containing 14C-GSK1265744B is being studied in HIV-associated lipodystrophy syndrome, a condition involving fat redistribution in people living with HIV. The radiolabeled form is used in clinical pharmacology research to characterize the drug's recovery, excretion, and pharmacokinetic profile rather than to treat patients directly.
GSK plc, which trades under the ticker GSK, is the developer of GSK1265744B containing 14C-GSK1265744B. The company sponsored the clinical pharmacology study evaluating this radiolabeled compound in healthy adult subjects.
GSK1265744B containing 14C-GSK1265744B is in Phase 1 development. It is an investigational agent and has not been approved for commercial use. The single Phase 1 study has been completed, and no active trials are currently listed.
GSK1265744B containing 14C-GSK1265744B was evaluated in one completed Phase 1 trial, NCT01848340. The study investigated the recovery, excretion, and pharmacokinetics of a single oral dose of 14C-GSK1265744 and described the pharmacokinetics of a supratherapeutic dose in healthy adult subjects. It enrolled 16 participants in the United States.
Yes, GSK1265744B containing 14C-GSK1265744B is also known as GSK1265744B (sodium salt) containing 14C-GSK1265744B. The sodium salt form is the specific chemical version used in the radiolabeled study material. Both names refer to the same investigational compound developed by GSK plc.