NCT00404378

Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]

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]

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Nausea and Vomiting, Chemotherapy-Induced

Interventions

Type	Name	Description
DRUG	ketoconazole	Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
DRUG	casopitant 100 mg	Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time
DRUG	Casopitant 50 mg	Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

Timeline

• Start date: 2006-10-20
• Primary completion: 2007-01-05
• Completion: 2007-01-05
• First posted: 2006-11-28
• Last updated: 2017-09-12

Locations

1 site across 1 country: United States