CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 188 enrolled
Drug / intervention
90 mg MK-0517 (PS80) +11 moredrug
Likely dose
90 mg MK-0517 (PS80)from 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/NCT00990821
NCT00990821Phase 1Completed
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A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects

Merck Sharp & Dohme LLC·interventional·Posted Oct 7, 2009·Updated Aug 19, 2015

In Brief

A Phase 1 clinical trial evaluating 90 mg MK-0517 (PS80), 100 mg MK-0517 (PS80), and 10 other interventions for Chemotherapy-Induced Nausea and Vomiting and Postoperative Nausea and Vomiting. Completed, enrolled 188 participants.

Detailed Summary

This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or 115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-Induced Nausea and Vomiting, Postoperative Nausea and Vomiting
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 7, 2009
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2005
Study CompletionJan 1, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.7 years ago

Interventions

90 mg MK-0517 (PS80)drug

MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes

100 mg MK-0517 (PS80)drug

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

100 MK-0517 (PS80) + 2 mg midazolamdrug

MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.

115 mg MK-0517 (PS80)drug

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

150 mg MK-0517 (PS80)drug

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

40 mg MK-0517 (non-PS80)drug

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

100 mg MK-0517 (non-PS80)drug

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

150 mg MK-0517 (Non-PS80)drug

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

Placebodrug

Placebo matching MK-0517

40 mg Aprepitantdrug

Aprepitant, oral, tablet, single dose

125 mg Aprepitantdrug

Aprepitant oral tablet, single dose

2 mg Midazolamdrug

Midazolam oral tablet, single dose