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Clinical Trials/NCT00448032
NCT00448032
Completed
Phase 1

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

Wyeth is now a wholly owned subsidiary of Pfizer0 sitesNovember 2006
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ConditionsDiabetes Mellitus
DrugsPPM-204

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Primary Endpoint
Safety
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
March 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety

Secondary Outcomes

  • Pharmacokinetics/Pharmacodynamics

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