drugset / Trial / NCT02549014
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064 plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment of MK-1064 in humans, the study protocol allows for modifications to the outlined dose, dosing regimen and/or clinical or laboratory procedures, if required to address study objectives and/or to ensure appropriate safety monitoring of participants.
Timeline
- Start
- 2009-07-06
- Primary completion
- 2009-09-29
- Completion
- 2009-09-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-1064 | Small molecule | 5 mg | Oral |
| Subject | MK-1064 | Small molecule | 10 mg | Oral |
| Subject | MK-1064 | Small molecule | 25 mg | Oral |
| Subject | MK-1064 | Small molecule | 50 mg | Oral |
| Subject | MK-1064 | Small molecule | 100 mg | Oral |
| Subject | MK-1064 | Small molecule | 150 mg | Oral |
| Subject | MK-1064 | Small molecule | 200 mg | Oral |
| Subject | MK-1064 | Small molecule | 250 mg | Oral |
Indications
No indication recorded.