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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00511654 | 28-day Repeat Dose and Drug Interaction Study With Orvepitant (GW823296) | PHASE1 | COMPLETED | 36 | — | — | Jun 12, 2007 | Jan 11, 2008 | Aug 4, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Subjects in Group 1 receiving GW823296 | EXPERIMENTAL | Subjects will receive single dose of GW823296 on Day 1 followed by a wash-out period of 1 week. The subjects will then be administered GW823296 for 28 days in the repeat dosing period. |
| Subjects in Group 1 receiving placebo | PLACEBO_COMPARATOR | Subjects will receive single dose of placebo on Day 1 followed by a wash-out period of 1 week. The subjects will then be administered placebo for 28 days in the repeat dosing period. |
| Subjects in Group 2 and 3 receiving GW823296 | EXPERIMENTAL | Subjects will receive single dose of midazolam on Day 1 followed by wash-out period of one day. Further the subjects will be administered GW823296 on Day 3 of single dose period followed by a wash-out period of 1 week. The subjects will then be administered a single dose of GW823296 for 28 days (Day 1 to Day 28 of repeat dosing period) and a single dose of midazolam on Day 29 of repeat dosing period. |
| Subjects in Group 2 and 3 receiving placebo | PLACEBO_COMPARATOR | Subjects will receive single dose of midazolam on Day 1 followed by wash-out period of one day. Further the subjects will be administered placebo on Day 3 of single dose period followed by a wash-out period of 1 week. The subjects will then be administered a single dose of placebo for 28 days (Day 1 to Day 28 of repeat dosing period) and a single dose of midazolam on Day 29 of repeat dosing period. |
| Name | Type | Description |
|---|---|---|
| GW823296 tablet | DRUG | GW823296 immediate release tablets will be available as white film-coated tablets containing 5 milligrams (mg) and 20 mg of GW823296 for oral administration. |
| GW823296 matching placebo | DRUG | Matching placebo tablets will be identical in appearance to the GW823296 tablets. |
| Midazolam | DRUG | Midazolam will be administered as 5 milliliter (mL) of an intravenous solution for oral application (5 mg/5 mL, Dormicum). |
Inclusion Criteria: * Healthy as determined by a Physician Responsible, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring. A subject with a clinical abnormality or laboratory variables outside the reference range for the population being stu...