Last updated: 11/04/2018 09:21:34

Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812

GSK study ID
NAA105416
See study documents
Clinicaltrials.gov ID
NCT00411866
EudraCT ID
2006-001605-28
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: Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg
Trial description: The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Blood sampling over period of 336 hours post dosing with SB-773812

Timeframe: over period of 336 hours post dosing

Secondary outcomes:

Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.

Timeframe: over 48 hours post SB-773812 dosing.

Interventions:
  • Drug: SB773812
  • Drug: Ketoconazole
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Schizophrenia
    Product
    SB773812
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to October 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy
    • Body Weight >/=50kg and BMI 18.5-29.9 kg/m2 inclusive
    • Normal 12-lead ECG, physical examination and lab screen Exclusion criteria:
    • A history of psychiatric illness,
    • A history or presence gastro-intestinal,
    • A hepatic or renal disease or orthostatic hypotension.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dundee, United Kingdom, DD1 9SY
    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
    2007-10-10

    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 NAA105416 can be found on the GSK Clinical Study Register.
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