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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00460707 |
Purpose
Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects |
Drug: Casopitant Drug: Ketoconazole |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase I, Randomized, Double-Blind Study to Assess the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of Repeat Oral Dosing of Casopitant [GW679769] in Healthy Subjects |
| Enrollment: | 72 |
| Study Start Date: | April 2007 |
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| United States, Kansas | |
| GSK Investigational Site | |
| Overland Park, Kansas, United States, 66211 | |
| United States, New York | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14202 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43212 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00460707 History of Changes |
| Other Study ID Numbers: | NKV109990 |
| Study First Received: | April 12, 2007 |
| Last Updated: | October 9, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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GW679769 casopitant ketoconazole healthy adult subjects |
|
Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |