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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00945321
First received: July 23, 2009
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
Drug: aprepitant 165 mg
Drug: Comparator: aprepitant 185 mg
Drug: Comparator: fosaprepitant 150 mg
Drug: Comparator: aprepitant with food
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 [ Time Frame: Through 72 Hours Postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
aprepitant 165 mg
Drug: aprepitant 165 mg
Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.
Active Comparator: 2
aprepitant 185 mg
Drug: Comparator: aprepitant 185 mg
Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.
Experimental: 3
fosaprepitant 150 mg
Drug: Comparator: fosaprepitant 150 mg
Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.
Experimental: 4
aprepitant with food
Drug: Comparator: aprepitant with food
Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945321

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00945321     History of Changes
Other Study ID Numbers: 0869-165, 2009_624, MK-0869-165
Study First Received: July 23, 2009
Results First Received: April 22, 2010
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014