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metyrapone

Phase 1

Depressive Disorder and Anxiety Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Sep 11, 2017

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

metyrapone · 1 trial · 1 indication

Phase 1 1
NCT00426608To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.Depressive Disorder and Anxiety Disorders
COMPLETED20 Analytics
PHASE1COMPLETED
To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.
Depressive Disorder and Anxiety DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Blood levels of ACTH: over 24 hours
Over 24 hours

Secondary Endpoints

Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours
Over 24 hours
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Study Design & Arms

AllocationRANDOMIZED
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Session 1EXPERIMENTALSubjects 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 2EXPERIMENTALSubjects 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 3EXPERIMENTALSubjects 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 4EXPERIMENTALSubjects 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 5EXPERIMENTALSubjects 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.

Interventions

NameTypeDescription
metyraponeDRUGMetyrapone will be available as 250 mg dose capsule.
alprazolamDRUGAlprazolam capsules will be available with dose strength of 0.25mg
placeboDRUGGSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.
GSK561679DRUGGSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion: * Healthy male subjects * non-smoker * normal ECG Exclusion: * shift workers * vegetarians * persons who travel distances * persons participating in a psychology or psychiatry course

Countries:United Kingdom
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Frequently asked questions about metyrapone

What is metyrapone used for?

Metyrapone is being investigated for use in depressive disorder and anxiety disorders. It is a small molecule in Phase 1 clinical development. The drug is being studied for its effects on the body's system that controls the balance of many hormones, which may relate to these psychiatric conditions.

Who makes metyrapone?

Metyrapone is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this small molecule for psychiatric indications, specifically depressive disorder and anxiety disorders.

What phase is metyrapone in?

Metyrapone is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for depressive disorder and anxiety disorders. One Phase 1 trial has been completed, involving 20 participants.

What clinical trials is metyrapone in?

Metyrapone has one completed clinical trial registered as NCT00426608. This Phase 1 study investigated the effects of GSK561679 on the body's hormone-balancing system. The trial enrolled 20 healthy male volunteers in the United Kingdom, with participants aged 18 years and older.

Is metyrapone the same as GSK561679?

Yes, metyrapone is also known as GSK561679. The clinical trial NCT00426608, which studied metyrapone, is titled 'To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.' This alternative name is used in the trial registration.