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metyrapone · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Session 1 | EXPERIMENTAL | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 gram per kilogram (g/kg) and Dose 2 of AEBCD sequence. In AEBCD sequence A is placebo, E Alprazolam, B GSK6561679 10 milligram (mg), C GSK6561679 50 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 2 | EXPERIMENTAL | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of BACED sequence. In BACED sequence B is GSK6561679 10 mg, A placebo, C GSK6561679 50 mg, E Alprazolam, and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 3 | EXPERIMENTAL | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of CBEAD sequence. In CBEAD sequence C is GSK6561679 50 mg, B GSK6561679 10 mg, E Alprazolam, A placebo, and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 4 | EXPERIMENTAL | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of ECABD sequence. In ECABD sequence E is Alprazolam, C is GSK6561679 50 mg, A placebo, B GSK6561679 10 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 5 | EXPERIMENTAL | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of GSK561679 400 mg and alprazopam placebo. Wash-out period will be of 7 days. |
| Name | Type | Description |
|---|---|---|
| metyrapone | DRUG | Metyrapone will be available as 250 mg dose capsule. |
| alprazolam | DRUG | Alprazolam capsules will be available with dose strength of 0.25mg |
| placebo | DRUG | GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules. |
| GSK561679 | DRUG | GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg. |
Inclusion: * Healthy male subjects * non-smoker * normal ECG Exclusion: * shift workers * vegetarians * persons who travel distances * persons participating in a psychology or psychiatry course
Metyrapone is a small molecule drug being developed by GSK plc under the ticker GSK for depressive disorder and anxiety disorders. It is in Phase 1 clinical development in the psychiatry therapeutic area. The compound is a CYP11B1 inhibitor and is also known by the identifier GSK561679.
Metyrapone is being studied for depressive disorder and anxiety disorders. It is an investigational therapy in Phase 1 development and has not been approved for any indication. The research focuses on its potential effects in psychiatry, specifically on hormonal systems relevant to these conditions.
Metyrapone targets CYP11B1, an enzyme involved in hormone synthesis. It acts as an inhibitor of this target. By inhibiting CYP11B1, the drug is designed to modulate the body's hormone balance, which is being explored in the context of depressive and anxiety disorders.
Metyrapone is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program investigating metyrapone for psychiatric indications.
Metyrapone is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency for any indication. The Phase 1 program has completed one trial.
Metyrapone has been studied in one completed Phase 1 trial, NCT00426608, titled "To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones." The trial enrolled 20 healthy male volunteers in the United Kingdom and was controlled and randomized.
Yes, metyrapone is also known as GSK561679. GSK561679 is the development code used by GSK plc for this compound. Both names refer to the same investigational drug targeting CYP11B1.