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Completed

NCT Number: NCT00945321

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

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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aprepitant 165 mg

Drug

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

Comparator: aprepitant 185 mg

Drug

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

Comparator: fosaprepitant 150 mg

Drug

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

Comparator: aprepitant with food

Drug

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 24, 2009
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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