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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00426608
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Depressive Disorder and Anxiety Disorders Drug: metyrapone Drug: alprazolam Drug: placebo Drug: GSK561679 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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
Actual Study Start Date : October 6, 2006
Primary Completion Date : January 8, 2007
Study Completion Date : January 8, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Session 1
Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 gram per kilogram (g/kg) and Dose 2 of AEBCD sequence. In AEBCD sequence A is placebo, E Alprazolam, B GSK6561679 10 milligram (mg), C GSK6561679 50 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days.
Drug: metyrapone
Metyrapone will be available as 250 mg dose capsule.
Drug: alprazolam
Alprazolam capsules will be available with dose strength of 0.25mg
Drug: 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.
Drug: GSK561679
GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
Other Names:
  • Single dose of GSK561679
  • Single dose of metyrapone
  • Single dose of placebo
  • Single dose of alprazolam
Experimental: Session 2
Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of BACED sequence. In BACED sequence B is GSK6561679 10 mg, A placebo, C GSK6561679 50 mg, E Alprazolam, and D GSK6561679 400 mg. Wash-out period will be of 7 days.
Drug: metyrapone
Metyrapone will be available as 250 mg dose capsule.
Drug: alprazolam
Alprazolam capsules will be available with dose strength of 0.25mg
Drug: 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.
Drug: GSK561679
GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
Other Names:
  • Single dose of GSK561679
  • Single dose of metyrapone
  • Single dose of placebo
  • Single dose of alprazolam
Experimental: Session 3
Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of CBEAD sequence. In CBEAD sequence C is GSK6561679 50 mg, B GSK6561679 10 mg, E Alprazolam, A placebo, and D GSK6561679 400 mg. Wash-out period will be of 7 days.
Drug: metyrapone
Metyrapone will be available as 250 mg dose capsule.
Drug: alprazolam
Alprazolam capsules will be available with dose strength of 0.25mg
Drug: 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.
Drug: GSK561679
GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
Other Names:
  • Single dose of GSK561679
  • Single dose of metyrapone
  • Single dose of placebo
  • Single dose of alprazolam
Experimental: Session 4
Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of ECABD sequence. In ECABD sequence E is Alprazolam, C is GSK6561679 50 mg, A placebo, B GSK6561679 10 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days.
Drug: metyrapone
Metyrapone will be available as 250 mg dose capsule.
Drug: alprazolam
Alprazolam capsules will be available with dose strength of 0.25mg
Drug: 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.
Drug: GSK561679
GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
Other Names:
  • Single dose of GSK561679
  • Single dose of metyrapone
  • Single dose of placebo
  • Single dose of alprazolam
Experimental: Session 5
Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of GSK561679 400 mg and alprazopam placebo. Wash-out period will be of 7 days.
Drug: metyrapone
Metyrapone will be available as 250 mg dose capsule.
Drug: alprazolam
Alprazolam capsules will be available with dose strength of 0.25mg
Drug: 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.
Drug: GSK561679
GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
Other Names:
  • Single dose of GSK561679
  • Single dose of metyrapone
  • Single dose of placebo
  • Single dose of alprazolam


Outcome Measures

Primary Outcome Measures :
  1. Blood levels of ACTH: over 24 hours [ Time Frame: Over 24 hours ]

Secondary Outcome Measures :
  1. Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours [ Time Frame: Over 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00426608     History of Changes
Other Study ID Numbers: CRS105511
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
HPA axis,
Healthy volunteers
hormones,
GSK561679,
cortisol,

Additional relevant MeSH terms:
Depressive Disorder
Depression
Anxiety Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Alprazolam
Metyrapone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Enzyme Inhibitors