NCT00460707

A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults

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 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Nausea and Vomiting, Chemotherapy-Induced

Interventions

Type	Name	Description
DRUG	Casopitant 150 mg	Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.
DRUG	Ketoconazole	Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days).
DRUG	Casopitant 150 mg matching placebo	Casopitant 150 mg matching placebo will be available as white, film-coated tablets.
DRUG	Casopitant 50 mg	Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach.
DRUG	Casopitant 50 mg matching placebo	Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.

Timeline

• Start date: 2007-04-16
• Primary completion: 2007-08-27
• Completion: 2007-08-27
• First posted: 2007-04-16
• Last updated: 2017-08-03

Locations

3 sites across 1 country: United States