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.

First Received on January 23, 2007. Last Updated on June 4, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00426608

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 I

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:

Drug Information available for: Metyrapone Alprazolam

U.S. FDA Resources

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:

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 February 09, 2012