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

Sponsored by:	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

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Alprazolam Metyrapone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
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

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)

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, Cambridgeshire
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CRS105511
Study First Received:	January 23, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00426608
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

cortisol,
Healthy volunteers
GSK561679,
HPA axis,
hormones,

Study placed in the following topic categories:

Hydrocortisone
Alprazolam
Metyrapone

Cortisol succinate
Hydrocortisone acetate
Healthy

Additional relevant MeSH terms:

Antimetabolites
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Enzyme Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009