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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00975936 | Phase 0 Microdose Study | PHASE1 | COMPLETED | 12 | — | — | Sep 21, 2009 | Nov 12, 2009 | Jun 27, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| [14C]-GSK706769 | EXPERIMENTAL | Single dose of 50µg \[14C\]-GSK706769 containing 250 nCi |
| [14C]-GSK706769 + Ketoconazole | EXPERIMENTAL | An oral, 5-day repeat dose of 200 mg Ketoconazole (Q12) with a concomitant single oral dose of 50 µg \[14C\]-GSK706769 containing 250 nCi on day 3. |
| Name | Type | Description |
|---|---|---|
| [14C]-GSK706769 | DRUG | 50µg \[14C\]-GSK706769 containing 250 nCi |
| Ketoconazole | DRUG | 200 mg Ketoconazole (Q12) |
Inclusion Criteria: * Males 18-50 years of age inclusive, at the time of signing the informed consent. * AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin ...