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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00404378 |
This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: ketoconazole Drug: casopitant |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Two Period, Fixed Sequence Study of Healthy Subjects to Assess the Effect of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of [GW679769] |
Enrollment: | 15 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NKV105093 |
Study First Received: | November 27, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00404378 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Casopitant Pharmacokinetics Ketoconazole Healthy subjects Drug interaction |
Anti-Infective Agents Antifungal Agents Healthy Ketoconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Ketoconazole Pharmacologic Actions |