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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: PPM-204

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448032

3180A1-107

Details and patient eligibility

About

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

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind