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Sponsors and Collaborators: |
GlaxoSmithKline Shionogi |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00774111 |
A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and etravirine
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GSK1349572 |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Open Label, Two Period, Single Fixed-Sequence Crossover Study to Evaluate the Effect of Etravirine on GSK1349572 Pharmacokinetics in Healthy Adult Subjects (ING111603) |
Enrollment: | 16 |
Study Start Date: | October 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sequence 1: Experimental |
Drug: GSK1349572
GSK1349572 50 mg in combination with Etravirine
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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: | 111603 |
Study First Received: | October 16, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00774111 |
Health Authority: | United States: Food and Drug Administration |
healthy volunteer pharmacokinetics GSK1349572 integrase etravirine |
Healthy |