NCT00945321

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 30, 2010

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

28 days

First QC Date

July 23, 2009

Results QC Date

April 22, 2010

Last Update Submit

January 16, 2015

Conditions

Chemotherapy-Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

  • 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

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

    Through 72 Hours Postdose

Study Arms (4)

1

ACTIVE COMPARATOR

aprepitant 165 mg

Drug: aprepitant 165 mg

2

ACTIVE COMPARATOR

aprepitant 185 mg

Drug: Comparator: aprepitant 185 mg

3

EXPERIMENTAL

fosaprepitant 150 mg

Drug: Comparator: fosaprepitant 150 mg

4

EXPERIMENTAL

aprepitant with food

Drug: Comparator: aprepitant with food

Interventions

aprepitant 165 mgDRUG

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

1
Comparator: aprepitant 185 mgDRUG

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

2
Comparator: fosaprepitant 150 mgDRUG

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

3
Comparator: aprepitant with foodDRUG

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

4

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is in good health
  • Subject is a nonsmoker
  • Subject is willing to comply with the study restrictions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27121336RESULT

MeSH Terms

Conditions

Vomiting

Interventions

AprepitantFood

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 28, 2015

Results First Posted

June 30, 2010

Record last verified: 2015-01