Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects

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Overview

A study evaluating the safety and pharmacokinetics of multiple oral doses of an investigational oral diabetic agent when given to healthy Japanese male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Conditions

Diabetes Mellitus

Interventions

PPM-204DRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men, aged 20 to 45 years, inclusive * Body mass index in the range of 17.6 to 26.4 kg/m2 * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) Exclusion Criteria: * History of cardiac, thyroid, muscle, and kidney abnormalities * History of NSAID induced bronchospasm or asthma * History of any clinically important allergies

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Safety

Secondary Outcomes

Pharmacokinetics/Pharmacodynamics

Data from ClinicalTrials.gov

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