Last updated: 11/04/2018 05:52:21

Relative Bioavailability Study on a single dose of GW842166X in healthy male and female subjects.

GSK study ID
CBA109358
Clinicaltrials.gov ID
NCT00536497
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A 2 part open-label, randomised, crossover study to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers
Trial description: GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Plasma GW842166 Cmax and AUC (O-Infinity)

Timeframe: Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose)

Secondary outcomes:

Plasma GW842166 AUC (0-t), tlag,tmax and t1/2

Timeframe: Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose)

Interventions:
  • Drug: GW842166X
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    GW842166
    Collaborators
    Not applicable
    Study date(s)
    October 2007 to January 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
    • Healthy as judged by a responsible physician.
    • Positive pre-study urine screen for drugs of abuse or alcohol breath test.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
    • Healthy as judged by a responsible physician.
    Exclusion criteria:
    • Positive pre-study urine screen for drugs of abuse or alcohol breath test.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website