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

Merck Sharp & Dohme LLC24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

MK-1006DRUG

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.

PlaceboDRUG

Matching placebo to MK-1006 in a single oral dose

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants Who Experienced at Least One Adverse Event

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

Time frame: from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)

Number of Participants Who Discontinued Treatment Due to an Adverse Event

Time frame: up to approximately 17 days

Secondary Outcomes

Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006

AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.

Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)

Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006

AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.

Data from ClinicalTrials.gov

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