To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: Single dose of metyrapone (Drug); Single dose of alprazolam (Drug); Single dose of placebo (Drug); Single dose of GSK561679 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MBChB, DA(SA), Dip Pharm Med, Study Director, Affiliation: GlaxoSmithKline
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).
Clinical Details
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
Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Blood levels of ACTH: over 24 hours
Secondary outcome: Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours
Questionnaires: each visit
Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
GSK Clinical Trials Call Center, Cambridge CB2 2GG, United Kingdom
Additional Information
Starting date: October 2006
Ending date: January 2007
Last updated: April 16, 2008
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