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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
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
Observational study model:
Not applicable
Primary completion date:
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)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
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
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