Last updated: 11/04/2018 10:08:34

15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.

GSK study ID
OXS104092
See study documents
Clinicaltrials.gov ID
NCT00495729
EudraCT ID
2006-002121-23
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: A single-blind, randomised, placebo-controlled, 15 day repeated-dose study to evaluate the safety, tolerability and pharmacokinetics of SB-649868 and its interaction with the CYP3A4 isoenzyme in healthy male subjects.
Trial description: Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

-AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days)

Timeframe: after the SD and 14 days RD period (15 days)

- SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)

Timeframe: on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)

- Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15

Timeframe: on days -10,1,4,7 and 15

Secondary outcomes:

Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.

Timeframe: on days -7, 7 and 14.

Interventions:
  • Drug: SB-649868
  • Drug: Placebo
  • Drug: Simvastatin
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sleep Initiation and Maintenance Disorders
    Product
    SB649868
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to August 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Healthy adult male subjects aged between 18 and 65 years of age inclusive.
    • Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
    • The subject has a positive pre-study urine drug/ alcohol urine screen.
    • A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy adult male subjects aged between 18 and 65 years of age inclusive.
    • Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
    • Healthy as judged by responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
    • Subjects will have blood pressure measurements within the normal range for healthy volunteers.
    Exclusion criteria:
    • The subject has a positive pre-study urine drug/ alcohol urine screen.
    • A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
    • Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
    • Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    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
    2007-04-08

    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 OXS104092 can be found on the GSK Clinical Study Register.
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