A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)

Phase 1

Completed

• Conditions: Chemotherapy-Induced Nausea and Vomiting
• Interventions: Drug: aprepitant 165 mg

• Registration Number: NCT00945321
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Results First Submitted: 2010-04-22
• Results First Submitted QC: 2010-05-26
• Results First Posted: 2010-06-30
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Subject is in good health
• Subject is a nonsmoker
• Subject is willing to comply with the study restrictions

Exclusion Criteria

• Subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe
• Subject has a history of stroke, seizures, or major neurological disorder
• Subject has a history of cancer
• Subject consumes more than two alcoholic drinks per day
• Subject consumes more than three caffeinated beverages daily

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	aprepitant 165 mg	aprepitant 165 mg

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.	Through 72 Hours Postdose
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg	Through 72 Hours Postdose