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”

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).

Study Type: Interventional

Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: January 2007

Intervention(s) in this Clinical Trial

• Drug: Single dose of metyrapone
• Drug: Single dose of alprazolam
• Drug: Single dose of placebo
• Drug: Single dose of GSK561679

Primary Measures

• Blood levels of ACTH: over 24 hours

Secondary Measures

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

Inclusion:

• Healthy male subjects
• non-smoker
• normal ECG

Exclusion:

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MBChB, DA(SA), Dip Pharm Med Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426608

Study ID Number: CRS105511

ClinicalTrials.gov Identifier: NCT00426608

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency