MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel A: MK-1006 15/30/45

Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Group Type EXPERIMENTAL

MK-1006

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Matching placebo to MK-1006 in a single oral dose

Panel B: MK-1006 60/80/60 fed

Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Group Type EXPERIMENTAL

MK-1006

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Matching placebo to MK-1006 in a single oral dose

Panel C: MK-1006 100/140/170

Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Group Type EXPERIMENTAL

MK-1006

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Matching placebo to MK-1006 in a single oral dose

Interventions

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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.

Intervention Type DRUG

Placebo

Matching placebo to MK-1006 in a single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese male or female between 20 to 64 years of age
* Diagnosis of type 2 diabetes
* Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent

Exclusion Criteria

* Subject has a history of type 1 diabetes mellitus
* Subject has a clinical diagnosis of glaucoma
* Subject has donated blood or participated in another clinical study in the past 12 weeks
* Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No