drugset / Trial / NCT00990821

A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)

NCT00990821

Phase 1 Completed 188 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-01
Primary completion
2005-12
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified 40 mg Oral
Subject Aprepitant Other / unclassified 125 mg Oral
Subject Midazolam Small molecule 2 mg Oral
Subject fosaprepitant dimeglumine Unknown 40 mg Intravenous
Subject fosaprepitant dimeglumine Unknown 90 mg Intravenous
Subject fosaprepitant dimeglumine Unknown 100 mg Intravenous
Subject fosaprepitant dimeglumine Unknown 115 mg Intravenous
Subject fosaprepitant dimeglumine Unknown 150 mg Intravenous