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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01371812 | GSK2239633 FTIH Study | PHASE1 | COMPLETED | 24 | — | — | Mar 29, 2011 | Jul 1, 2011 | Jul 21, 2017 | 1 | Netherlands |
| NCT01086462 | Intravenous Microdose Pharmacokinetic (PK) Study With [14C]-GSK2239633 | PHASE1 | COMPLETED | 6 | — | — | Jan 21, 2010 | Feb 22, 2010 | Jul 18, 2017 | 1 | Netherlands |
adverse events and clinically relevant changes in safety parameters - 12-lead ECG, telemetry, vital signs (systolic and diastolic blood pressure, heart rate, temperature), clinical laboratory data (haematology, clinical chemistry, urinalysis).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Interlocking design with Cohort 2. Single dose; treatment period over 2 days such that one subject will receive GSK2239633 and one subject will receive placebo on Day 1. The remaining subjects will be dosed on day 2 of each treatment period assuming adequate safety from Day 1. Placebo and an escalation of GSK2239633 from 150mg, to 600mg, to 1200mg and 1200mg with a FDA high fat/high calorie meal, will be administered over the 13 week long study allowing adequate washout period between doses. |
| Cohort 2 | EXPERIMENTAL | Interlocking design with Cohort 1. Single dose; treatment period over 2 days such that one subject will receive GSK2239633 and one subject will receive placebo on Day 1. The remaining subjects will be dosed on day 2 of each treatment period assuming adequate safety from Day 1. Placebo and an escalation of GSK2239633 from 300mg, to 900mg, and 1500mg, will be administered over the 13 week long study allowing adequate washout period between doses. |
| GSK2239633 | EXPERIMENTAL | Single dose infusion of study drug over 15 minutes |
| Name | Type | Description |
|---|---|---|
| GSK2239633 | DRUG | Drug will be orally administered at the doses and time points detailed in the 'arms' section. |
| Placebo | DRUG | Placebo will be orally administered to 4 subjects in each treatment period of each cohort. |
Inclusion Criteria: * Male between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitorin...