Last updated: 11/07/2018 02:43:51

A single-centre open label study to investigate the effect of repeat doses of SB-649868 on the pharmacokinetics of Simvastatin and Atorvastatin in healthy male volunteers.N/A

GSK study ID
109652
Clinicaltrials.gov ID
EudraCT ID
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-centre open label study to investigate the effect of repeat doses of SB-649868 on the pharmacokinetics of Simvastatin and Atorvastatin in healthy male volunteers.
Trial description: The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions after repeat doses of SB-649868, at the same time as SB-649868 and 2h before SB-649868.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Safety and tolerability evaluated by adverse event monitoring, ECG, Vital Signs, physical examination, laboratory values and Romberg/heel to toe tests; plasma analysis of Simvastatin and Atorvastatin and active metabolites.

Timeframe: screening period of 28 days followed 17 days clinical duration plus a follow up visit 7-14 days post last dose

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Atorvastatin
  • Drug: Simvastatin
  • Drug: SB649868
  • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bettica P, Lavergne A, Zamuner S, Squassante L, Renzulli C. Effect of repeat doses of SB-649868 (an orexin antagonist) on the pharmacokinetics of Simvastatin and Atorvastatin in healthy male volunteers. APSS (2013) SLEEP 2013 Meeting (Associated Professional Sleep Societies - 27th Annual Meeting)
    Medical condition
    Sleep Disorders
    Product
    SB649868
    Collaborators
    Not applicable
    Study date(s)
    January 2010 to February 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • 1. Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. However,
    • Subjects with cTpn I values above 99th percentile of normal range of the selected assay should always be excluded from enrollment;
    • 1. History or presence of significant psychiatric neurological, musculo-skeletal , respiratory, gastrointestinal, hepatic, uncontrolled hypothyroidism. pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
    • 2. Subjects, who in the Investigator’s judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    Status
    Study Complete

    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    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
    2010-26-02

    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 109652 can be found on the GSK Clinical Study Register.
    Click here
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website