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

A Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Ppm-204 Administered Orally to Healthy Male Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448032

Enrollment

Unknown

Registered

2007-03-15

Start date

2006-11-30

Completion date

2007-03-31

Last updated

2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

DRUGPPM-204

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Pharmacokinetics/Pharmacodynamics	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026