Last updated: 11/04/2018 06:05:23

To investigate effects GSK561679 on part of the body's system that controls the balance of many of the hormones.

GSK study ID
CRS105511
See study documents
Clinicaltrials.gov ID
NCT00426608
EudraCT ID
2006-003589-32
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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).
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Blood levels of ACTH: over 24 hours

Timeframe: Over 24 hours

Secondary outcomes:

Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours

Timeframe: Over 24 hours

Interventions:
  • Drug: metyrapone
  • Drug: alprazolam
  • Drug: placebo
  • Drug: GSK561679
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Depressive Disorder and Anxiety Disorders
    Product
    verucerfont
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to January 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Inclusion:
    • Healthy male subjects
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-08-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study CRS105511 can be found on the GSK Clinical Study Register.
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    Access to clinical trial data by researchers
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