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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00866515 | Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole | PHASE1 | COMPLETED | 20 | — | — | Dec 22, 2008 | Mar 27, 2009 | Jul 18, 2017 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Ketoconazole 400mg OD days 1-6 |
| Placebo | PLACEBO_COMPARATOR | Placebo OD for 1 to 6 days |
| Name | Type | Description |
|---|---|---|
| Ketoconazole + GW642444M | DRUG | Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5 |
| Placebo + GW642444M | DRUG | Placebo to match D1-6 + GW642444M 25ug single dose on D5 |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...