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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder and Anxiety Disorders

Treatments: Drug: placebo; Drug: GSK561679; Drug: metyrapone; Drug: alprazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426608

CRS105511

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Healthy male subjects
• non-smoker
• normal ECG

Exclusion:

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

Trial design

20 participants in 5 patient groups

Session 1

Experimental group

Description:

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.

Treatment:

Drug: metyrapone

Drug: alprazolam

Drug: placebo

Drug: GSK561679

Session 2

Experimental group

Description:

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.

Treatment:

Drug: metyrapone

Drug: alprazolam

Drug: placebo

Drug: GSK561679

Session 3

Experimental group

Description:

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.

Treatment:

Drug: metyrapone

Drug: alprazolam

Drug: placebo

Drug: GSK561679

Session 4

Experimental group

Description:

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.

Treatment:

Drug: metyrapone

Drug: alprazolam

Drug: placebo

Drug: GSK561679

Session 5

Experimental group

Description:

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.

Treatment:

Drug: metyrapone

Drug: alprazolam

Drug: placebo

Drug: GSK561679