Trials / Completed
CompletedNCT00990821
A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 90 mg MK-0517 (PS80) | MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes |
| DRUG | 100 mg MK-0517 (PS80) | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
| DRUG | 100 MK-0517 (PS80) + 2 mg midazolam | 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. |
| DRUG | 115 mg MK-0517 (PS80) | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
| DRUG | 150 mg MK-0517 (PS80) | MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes |
| DRUG | 40 mg MK-0517 (non-PS80) | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
| DRUG | 100 mg MK-0517 (non-PS80) | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
| DRUG | 150 mg MK-0517 (Non-PS80) | MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds. |
| DRUG | Placebo | Placebo matching MK-0517 |
| DRUG | 40 mg Aprepitant | Aprepitant, oral, tablet, single dose |
| DRUG | 125 mg Aprepitant | Aprepitant oral tablet, single dose |
| DRUG | 2 mg Midazolam | Midazolam oral tablet, single dose |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2005-12-01
- Completion
- 2006-01-01
- First posted
- 2009-10-07
- Last updated
- 2015-08-19
- Results posted
- 2013-12-12
Source: ClinicalTrials.gov record NCT00990821. Inclusion in this directory is not an endorsement.