Last updated: 11/04/2018 05:59:57

A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects

GSK study ID
CR2100609
See study documents
Clinicaltrials.gov ID
NCT00504439
EudraCT ID
2004-002875-18
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 randomised, double-blind, placebo controlled, dose ascending, parallel group study to evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of SB-656933-AAA following repeated doses in healthy adult subjects. The pharmacokinetic interaction between repeated doses of SB-656933-AAA and single dose of simvastatin will also be assessed
Trial description: To assess safety of SB-656933 following repeat dosing for 14 days.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Assess safety of SB-656933 after repeat doses.

Timeframe: after repeat doses

Secondary outcomes:

Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.

Timeframe: 14 days of repeat dosing.

Interventions:
  • Drug: SB-656933-AAA
  • Drug: Matching 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
    Pulmonary Disease, Chronic Obstructive
    Product
    elubrixin
    Collaborators
    Not applicable
    Study date(s)
    June 2007 to September 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Healthy adult female, aged 18-65 years.
    • Female must not be able to have children.
    • Any serious medical condition.
    • Hepatitis B or C and/or HIV positive.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy adult female, aged 18-65 years.
    • Female must not be able to have children.
    • Non-smoking for the last 6 months.
    Exclusion criteria:
    • Any serious medical condition.
    • Hepatitis B or C and/or HIV positive.
    • Currently on HRT, or other medication except paracetamol.
    • Body Mass Index >30.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, NW10 7NS
    Status
    Terminated/Withdrawn
    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
    2007-06-09

    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 CR2100609 can be found on the GSK Clinical Study Register.
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