CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Fosaprepitant 150 mg +6 moredrug
Likely dose
Fosaprepitant 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01111851
NCT01111851Phase 1Completed

MK0869 and MK0517 Time-on-Target PET Study

Merck Sharp & Dohme LLC·interventional·Posted Apr 28, 2010·Updated Feb 25, 2015

In Brief

A Phase 1 clinical trial evaluating Fosaprepitant 150 mg, Aprepitant 165 mg, and 5 other interventions for Chemotherapy-Induced Nausea and Vomiting (CINV). Completed, enrolled 16 participants.

Detailed Summary

This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepitant at certain timepoints.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.2 years ago

Interventions

Fosaprepitant 150 mgdrug

a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal

Aprepitant 165 mgdrug

a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal

Aprepitant 250 mgdrug

a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal

Dexamethasone (12-8-16-16 mg)drug

Dexamethasone 12 mg will be administered orally 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg twice daily), and Day 4 (8 mg twice daily) with or without a meal.

Dexamethasone (12-8-8-16 mg)drug

Dexamethasone 12 mg will be administered orally 30 minutes after after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg), and Day 4 (8 mg twice daily) with or without a meal.

Ondansetrondrug

The intravenous (I.V.) infusion of ondansetron 32 mg will begin 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1 and will be administered as a 15-minute infusion

MK0999drug

I.V. infusion of MK0999 containing \~100 MBq (\~3 mCi) containing ≤ 5 ug of MK0999)