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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chemotherapy-Induced Nausea and Vomiting

Treatments: Drug: Comparator: aprepitant with food; Drug: Comparator: aprepitant 185 mg; Drug: aprepitant 165 mg; Drug: Comparator: fosaprepitant 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945321

2009_624

0869-165

MK-0869-165

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

1

Active Comparator group

Description:

aprepitant 165 mg

Treatment:

Drug: aprepitant 165 mg

2

Active Comparator group

Description:

aprepitant 185 mg

Treatment:

Drug: Comparator: aprepitant 185 mg

3

Experimental group

Description:

fosaprepitant 150 mg

Treatment:

Drug: Comparator: fosaprepitant 150 mg

4

Experimental group

Description:

aprepitant with food

Treatment:

Drug: Comparator: aprepitant with food