Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01848340 | An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects | PHASE1 | COMPLETED | 16 | — | — | May 1, 2013 | Jul 1, 2013 | Nov 4, 2013 | 1 | United States |
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 ...