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

Depressive Disorder and Anxiety Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426608
• Other study ID #: CRS105511
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2007
• Last updated: September 7, 2017
• Start date: October 6, 2006
• Est. completion date: January 8, 2007

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 8, 2007
• Est. primary completion date: January 8, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion:

• Healthy male subjects

• non-smoker

• normal ECG

Exclusion:

• shift workers

• vegetarians

• persons who travel distances

• persons participating in a psychology or psychiatry course

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder and Anxiety Disorders

Intervention

Drug:
• metyrapone
Metyrapone will be available as 250 mg dose capsule.
• alprazolam
Alprazolam capsules will be available with dose strength of 0.25mg
• placebo
GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.
• GSK561679
GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of ACTH: over 24 hours		Over 24 hours
Secondary	Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours		Over 24 hours

External Links

•   Results for study CRS105511 can be found on the GSK Clinical Study Register.