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Also known as GW823296 tablet, orvepitant
GW823296 · 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 ...
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GW823296 is an investigational small molecule developed by GSK plc for depressive disorder. It is a tablet formulation that has been studied in a Phase 1 clinical trial. GW823296 is also known as orvepitant. It is not approved and remains in early clinical development.
GW823296 is being developed for the treatment of depressive disorder, a psychiatric condition. The only recorded clinical study of GW823296 enrolled healthy volunteers rather than patients with depression, so its use in depressive disorder remains investigational and has not been established through later-stage trials.
GW823296 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 trial of GW823296 conducted in Germany. The drug is also referred to as orvepitant.
GW823296 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials of GW823296 are currently listed. It is an investigational agent and has not been approved by the FDA for any indication.
GW823296 has been evaluated in one completed Phase 1 trial, NCT00511654, titled a 28-day repeat dose and drug interaction study with orvepitant (GW823296). The trial enrolled 36 healthy volunteers in Germany, was randomized and placebo controlled, and included participants aged 18 years and older.
Yes, GW823296 is also known as orvepitant, and the tablet form is referred to as GW823296 tablet. The completed Phase 1 trial NCT00511654 lists the drug under both names, so searches for orvepitant and GW823296 refer to the same investigational compound developed by GSK.