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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

aprepitant 165 mg

Comparator: aprepitant 185 mg

Comparator: fosaprepitant 150 mg

Comparator: aprepitant with food

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

aprepitant 165 mg

aprepitant 185 mg

fosaprepitant 150 mg

aprepitant with food

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00945321

First Posted

July 23, 2009

Last Updated

January 16, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00945321

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-Induced Nausea and Vomiting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

aprepitant 165 mg

Arm Title

Arm Type

Active Comparator

Arm Description

aprepitant 185 mg

Arm Title

Arm Type

Experimental

Arm Description

fosaprepitant 150 mg

Arm Title

Arm Type

Experimental

Arm Description

aprepitant with food

Intervention Type

Drug

Intervention Name(s)

aprepitant 165 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: aprepitant 185 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: fosaprepitant 150 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: aprepitant with food

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

27121336

Citation

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.

Results Reference

result

Learn more about this trial

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

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