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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426608

Enrollment

Registered

2007-01-25

Start date

2006-10-06

Completion date

2007-01-08

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder and Anxiety Disorders

Keywords

HPA axis,, Healthy volunteers, hormones,, GSK561679,, cortisol,

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).

Interventions

DRUGmetyrapone

Metyrapone will be available as 250 mg dose capsule.

DRUGalprazolam

Alprazolam capsules will be available with dose strength of 0.25mg

DRUGplacebo

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

DRUGGSK561679

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Blood levels of ACTH: over 24 hours	Over 24 hours

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026