Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW823296 · 2 trials · 2 indications
| 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 | DRUG | - |
| 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...
Top 20 of 29 competitors
GW823296 is an investigational small molecule being studied for depressive disorder and in healthy subjects. It is in Phase 1 clinical development and is not approved by the FDA. Clinical trials have been completed in Germany and Australia.
GW823296 is being developed by GSK plc, which trades under the ticker GSK. The drug is currently in Phase 1 clinical development for depressive disorder and healthy subjects.
GW823296 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in depressive disorder and one in healthy subjects.
GW823296 has been studied in two completed Phase 1 trials. NCT00511654 was a 28-day repeat dose and drug interaction study in depressive disorder with 36 participants in Germany. NCT00675116 was a repeat dose study in healthy subjects with 30 participants in Australia.
Yes, GW823296 is also known as Orvepitant. The clinical trial NCT00511654 is titled "28-day Repeat Dose and Drug Interaction Study With Orvepitant (GW823296)", confirming the alternative name.