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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
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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
Completed
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

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