drugset / Trial / NCT00990821
A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |