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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00404378 |
Purpose
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 |
|---|---|---|
|
Healthy Subjects |
Drug: ketoconazole Drug: casopitant |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00404378 History of Changes |
| Other Study ID Numbers: | NKV105093 |
| Study First Received: | November 27, 2006 |
| Last Updated: | October 9, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Casopitant Pharmacokinetics Ketoconazole Healthy subjects Drug interaction |
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Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |