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

NCT ID: NCT00945321

Last Updated: 2015-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-03-31

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

aprepitant 165 mg

Group Type: ACTIVE_COMPARATOR

aprepitant 165 mg

Intervention Type: DRUG

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

2

aprepitant 185 mg

Group Type: ACTIVE_COMPARATOR

Comparator: aprepitant 185 mg

Intervention Type: DRUG

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

3

fosaprepitant 150 mg

Group Type: EXPERIMENTAL

Comparator: fosaprepitant 150 mg

Intervention Type: DRUG

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

4

aprepitant with food

Group Type: EXPERIMENTAL

Comparator: aprepitant with food

Intervention Type: DRUG

Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.

Interventions

aprepitant 165 mg

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

Intervention Type: DRUG

Comparator: aprepitant 185 mg

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

Intervention Type: DRUG

Comparator: fosaprepitant 150 mg

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

Intervention Type: DRUG

Comparator: aprepitant with food

Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Shadle CR, Murphy MG, Liu Y, Ho M, Tatosian D, Li SX, Blum RA. A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects. Clin Pharmacol Drug Dev. 2012 Jul;1(3):93-101. doi: 10.1177/2160763X12447304.

Reference Type: RESULT

PMID: 27121336 (View on PubMed)

Other Identifiers

2009_624

Identifier Type: -

Identifier Source: secondary_id

MK-0869-165

Identifier Type: -

Identifier Source: secondary_id

0869-165

Identifier Type: -

Identifier Source: org_study_id