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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00866515 |
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects. There will be two treatment periods each consisting of 7 days. During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects |
Drug: Active Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study |
Official Title: | A Double-Blind, Placebo-Controlled, Randomised, 2-Way Crossover Drug Interaction Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects Following co-Administration of GW642444M With Ketoconazole |
Estimated Enrollment: | 20 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active: Experimental
Ketoconazole 400mg OD days 1-6
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Drug: Active
Ketoconazole 400mg OD days 1-6
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo to match
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This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects. There will be two treatment periods each consisting of 7 days. During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112205 |
Study First Received: | January 22, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00866515 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy volunteer Ketoconazole Drug Interaction |
GW642444 pharmacokinetcs pharmacodynamics |
Anti-Infective Agents Antifungal Agents Healthy Ketoconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Ketoconazole Pharmacologic Actions |