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

Phase 1

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00448032
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-11
• Study Completion: 2007-03
• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-15
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics/Pharmacodynamics