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

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ClinicalTrials.gov Identifier: NCT00945321
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : June 30, 2010
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE July 23, 2009
First Posted Date  ICMJE July 24, 2009
Results First Submitted Date  ICMJE April 22, 2010
Results First Posted Date  ICMJE June 30, 2010
Last Update Posted Date January 28, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)
Official Title  ICMJE A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy-Induced Nausea and Vomiting
Intervention  ICMJE
  • Drug: aprepitant 165 mg
    Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.
  • Drug: Comparator: aprepitant 185 mg
    Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.
  • Drug: Comparator: fosaprepitant 150 mg
    Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.
  • Drug: Comparator: aprepitant with food
    Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.
Study Arms  ICMJE
  • Active Comparator: 1
    aprepitant 165 mg
    Intervention: Drug: aprepitant 165 mg
  • Active Comparator: 2
    aprepitant 185 mg
    Intervention: Drug: Comparator: aprepitant 185 mg
  • Experimental: 3
    fosaprepitant 150 mg
    Intervention: Drug: Comparator: fosaprepitant 150 mg
  • Experimental: 4
    aprepitant with food
    Intervention: Drug: Comparator: aprepitant with food
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2009)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00945321
Other Study ID Numbers  ICMJE 0869-165
2009_624
MK-0869-165
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP