Skip to main content
OpenTrials
Completed

NCT Number: NCT00426608

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder and Anxiety Disorders Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Healthy male subjects
  • non-smoker
  • normal ECG

Exclusion:

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

Treatment and study plan

Metyrapone

Drug

Metyrapone will be available as 250 mg dose capsule.

alprazolam

Drug

Alprazolam capsules will be available with dose strength of 0.25mg

Placebo

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

Drug

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

Primary outcomes

  1. Blood levels of ACTH: over 24 hours

    Time frame: Over 24 hours

Secondary outcomes

  1. Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours

    Time frame: Over 24 hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 25, 2007
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.