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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01627587 | A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole | PHASE1 | COMPLETED | 46 | — | — | Dec 12, 2011 | Feb 9, 2012 | Jun 15, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Ketoconazole-Part A | EXPERIMENTAL | Healthy Female volunteers of child bearing potential will receive Treatment A, B and C |
| Food-Part B | EXPERIMENTAL | Healthy Female Volunteers of child bearing potential will receive Treament D and E |
| Name | Type | Description |
|---|---|---|
| GSK221149 750 mg | DRUG | Treatment A: 750 mg GSK221149 single dose |
| Ketoconazole | DRUG | Treatment B: 400 mg of Ketoconazole single dose |
| GSK221149 100 mg | DRUG | Treatment C: 100mg of GSK221149 single dose |
| GSK221149 750 mg Fasted | DRUG | Treatment D: 750 mg of GSK221149 administered fasted |
| GSK221149 750 mg + Food | DRUG | Treatment E: 750 mg of GSK221149 administered with a high fat meal |
Inclusion Criteria: * ALT, alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%). * Single \[QTc, QTcB or QTcF\] less than 450 msec; or QTc less than 480 msec in subjects with Bu...