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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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PPM-204

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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3180A1-107

Identifier Type: -

Identifier Source: org_study_id