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

Merck Sharp & Dohme LLC42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy-Induced Nausea and Vomiting

Interventions

aprepitant 165 mgDRUG

Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.

Comparator: aprepitant 185 mgDRUG

Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.

Comparator: fosaprepitant 150 mgDRUG

Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg

Time frame: Through 72 Hours Postdose

Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.

Time frame: Through 72 Hours Postdose

Data from ClinicalTrials.gov

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