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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 29, 2014