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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00426608

Collaborator

(none)

Enrollment

Location

Arms

3.1

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder and Anxiety Disorders	Drug: metyrapone Drug: alprazolam Drug: placebo Drug: GSK561679	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Primary Purpose:

Diagnostic

Official Title:

Placebo-Controlled, Randomized, Blinded, Double-Dummy, Crossover Study to Investigate the Attenuation of ACTH Activation Induced by Metyrapone With a Single Dose of GSK561679 or Alprazolam in Healthy Volunteers

Actual Study Start Date :

Oct 6, 2006

Actual Primary Completion Date :

Jan 8, 2007

Actual Study Completion Date :

Jan 8, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: metyrapone Metyrapone will be available as 250 mg dose capsule. Drug: alprazolam Alprazolam capsules will be available with dose strength of 0.25mg 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. Drug: GSK561679 GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg. Other Names: Single dose of GSK561679 Single dose of metyrapone Single dose of placebo Single dose of alprazolam
Experimental: 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.	Drug: metyrapone Metyrapone will be available as 250 mg dose capsule. Drug: alprazolam Alprazolam capsules will be available with dose strength of 0.25mg 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. Drug: GSK561679 GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg. Other Names: Single dose of GSK561679 Single dose of metyrapone Single dose of placebo Single dose of alprazolam
Experimental: 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.	Drug: metyrapone Metyrapone will be available as 250 mg dose capsule. Drug: alprazolam Alprazolam capsules will be available with dose strength of 0.25mg 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. Drug: GSK561679 GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg. Other Names: Single dose of GSK561679 Single dose of metyrapone Single dose of placebo Single dose of alprazolam
Experimental: 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.	Drug: metyrapone Metyrapone will be available as 250 mg dose capsule. Drug: alprazolam Alprazolam capsules will be available with dose strength of 0.25mg 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. Drug: GSK561679 GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg. Other Names: Single dose of GSK561679 Single dose of metyrapone Single dose of placebo Single dose of alprazolam
Experimental: 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.	Drug: metyrapone Metyrapone will be available as 250 mg dose capsule. Drug: alprazolam Alprazolam capsules will be available with dose strength of 0.25mg 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. Drug: GSK561679 GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg. Other Names: Single dose of GSK561679 Single dose of metyrapone Single dose of placebo Single dose of alprazolam

Outcome Measures

Primary Outcome Measures

Blood levels of ACTH: over 24 hours [Over 24 hours]

Secondary Outcome Measures

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]