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

September 7, 2017 updated by: GlaxoSmithKline

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion:

  • Healthy male subjects
  • non-smoker
  • normal ECG

Exclusion:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood levels of ACTH: over 24 hours
Time Frame: Over 24 hours
Over 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Over 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2006

Primary Completion (Actual)

January 8, 2007

Study Completion (Actual)

January 8, 2007

Study Registration Dates

First Submitted

January 23, 2007

First Submitted That Met QC Criteria

January 23, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRS105511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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