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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00426608
First received: January 23, 2007
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Healthy Subjects
Drug: Single dose of metyrapone
Drug: Single dose of alprazolam
Drug: Single dose of placebo
Drug: Single dose of GSK561679
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Blood levels of ACTH: 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

Enrollment: 20
Study Start Date: October 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Single dose of metyrapone Drug: Single dose of alprazolam Drug: Single dose of placebo Drug: Single dose of GSK561679
    Other Names:
    • Single dose of metyrapone
    • Single dose of alprazolam
    • Single dose of placebo
    • Single dose of GSK561679
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426608

Locations
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00426608     History of Changes
Other Study ID Numbers: CRS105511
Study First Received: January 23, 2007
Last Updated: June 4, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
cortisol,
Healthy volunteers
GSK561679,
HPA axis,
hormones,

Additional relevant MeSH terms:
Alprazolam
Metyrapone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014