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Also known as GW823296, GW823296 tablet
Orvepitant · 3 trials · 2 indications
The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, \< 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and \> 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).
| Arm | Type | Description |
|---|---|---|
| Orvepitant 60 mg | EXPERIMENTAL | 60 mg/day |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm 1 | EXPERIMENTAL | Orvepitant 60 mg |
| 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 |
|---|---|---|
| orvepitant | DRUG | Neurokinin-1 (NK-1) antagonist |
| Placebo | OTHER | Inactive placebo to match orvepitant 60 mg dosage form |
| 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: * Aged 18-64 years, inclusive. * A primary diagnosis of noncombat-related Post traumatic Stress Disorder (PTSD) * Subjects with symptom severity considered to be at least moderate to severe. Exclusion Criteria: * Subjects whose symptoms are better accounted for by a diagnosis ...
Orvepitant is an investigational small molecule developed by GSK plc (ticker GSK) for psychiatric conditions, specifically depressive disorder and post-traumatic stress disorder. It is a TACR1 antagonist and remains in clinical development, with Phase 1 and Phase 2 studies completed.
Orvepitant targets TACR1, also known as the neurokinin 1 receptor. It acts as an antagonist at this receptor, blocking its activity. This mechanism is being explored in depressive disorder and post-traumatic stress disorder.
Orvepitant is being developed by GSK plc, which trades under the ticker GSK. GSK holds the development program for this TACR1 antagonist small molecule in psychiatry.
Orvepitant is in Phase 1 development according to the overall program status, though a Phase 2 trial has also been completed. It is investigational and has not been approved by the FDA for any indication.
Orvepitant has been studied in two completed trials: NCT01000493, a Phase 2 trial in adult post-traumatic stress disorder with 132 participants in the United States, and NCT00843011, a Phase 1 food and relative bioavailability study with 14 healthy volunteers in Italy.