To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-06

Study Completion Date

2007-01-08

Brief Summary

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A study to investigate the effects GSK561679 on part of the body's system that controls the balance of many of the hormones (including cortisol).

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Detailed Description

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Conditions

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Depressive Disorder and Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Study Groups

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Session 1

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.

Group Type EXPERIMENTAL

metyrapone

Intervention Type DRUG

Metyrapone will be available as 250 mg dose capsule.

alprazolam

Intervention Type DRUG

Alprazolam capsules will be available with dose strength of 0.25mg

placebo

Intervention Type 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

Intervention Type DRUG

GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Session 2

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.

Group Type EXPERIMENTAL

metyrapone

Intervention Type DRUG

Metyrapone will be available as 250 mg dose capsule.

alprazolam

Intervention Type DRUG

Alprazolam capsules will be available with dose strength of 0.25mg

placebo

Intervention Type 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

Intervention Type DRUG

GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Session 3

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.

Group Type EXPERIMENTAL

metyrapone

Intervention Type DRUG

Metyrapone will be available as 250 mg dose capsule.

alprazolam

Intervention Type DRUG

Alprazolam capsules will be available with dose strength of 0.25mg

placebo

Intervention Type 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

Intervention Type DRUG

GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Session 4

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.

Group Type EXPERIMENTAL

metyrapone

Intervention Type DRUG

Metyrapone will be available as 250 mg dose capsule.

alprazolam

Intervention Type DRUG

Alprazolam capsules will be available with dose strength of 0.25mg

placebo

Intervention Type 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

Intervention Type DRUG

GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Session 5

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.

Group Type EXPERIMENTAL

metyrapone

Intervention Type DRUG

Metyrapone will be available as 250 mg dose capsule.

alprazolam

Intervention Type DRUG

Alprazolam capsules will be available with dose strength of 0.25mg

placebo

Intervention Type 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

Intervention Type DRUG

GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Interventions

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metyrapone

Metyrapone will be available as 250 mg dose capsule.

Intervention Type DRUG

alprazolam

Alprazolam capsules will be available with dose strength of 0.25mg

Intervention Type DRUG

placebo

GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.

Intervention Type DRUG

GSK561679

GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Intervention Type DRUG

Other Intervention Names

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Single dose of GSK561679 Single dose of metyrapone Single dose of placebo Single dose of alprazolam

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects
* non-smoker
* normal ECG

Exclusion:

* shift workers
* vegetarians
* persons who travel distances
* persons participating in a psychology or psychiatry course

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes