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

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

Official title:

A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945321
• Other study ID #: 0869-165
• Secondary ID: 2009_624MK-0869-
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2009
• Last updated: January 16, 2015
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting

Intervention

Drug:
• aprepitant 165 mg
Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.
• Comparator: aprepitant 185 mg
Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.
• Comparator: fosaprepitant 150 mg
Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.
• Comparator: aprepitant with food
Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Shadle CR, Murphy MG, Liu Y, Ho M, Tatosian D, Li S, Blum R. A Single-Dose Bioequivalence and Food Effect Study with Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects. Clin Pharmacol Drug Devel. 2012;1(3):93-101. doi: 10.1177/216076

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.		Through 72 Hours Postdose	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site