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

PHASE1CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

April 16, 2007

Primary Completion Date

August 27, 2007

Study Completion Date

August 27, 2007

Conditions
Nausea and Vomiting, Chemotherapy-Induced
Interventions
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.

Trial Locations (3)

14202

GSK Investigational Site, Buffalo

43212

GSK Investigational Site, Columbus

66211

GSK Investigational Site, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00460707 - A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults | Biotech Hunter | Biotech Hunter