MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
NCT00791661 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2016-01-07
Summary
A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.
Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
Interventions
- DRUG
-
MK-1006
MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.
- DRUG
-
Matching placebo to MK-1006 in a single oral dose
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
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