Phase 1
Completed N=188
A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
Source: ClinicalTrials.gov NCT00990821 ↗Enrolled (actual)
188
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V — 29215; 24961; 31724 ng*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V |
29215; 24961; 31724 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is neither grossly overweight nor underweight for his/her height and body build
- Subject is in good health -Subject is a nonsmoker
- Subject is willing to avoid excessive alcohol consumption for the duration of the study
- Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
- Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study
Exclusion Criteria
- Subject has a history of multiple and/or severe allergies to drugs or food
- Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
- Subject has an infection, including Human immunodeficiency virus (HIV) infection
- Subject is a regular user of any illicit drug
- Subject consumes excessive amounts of alcohol
- Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages
- Subject currently uses on a regular basis, any prescription or non prescription medications
Data sourced from ClinicalTrials.gov (NCT00990821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.