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Completed

NCT Number: NCT00448032

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, 171-0014, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPM-204

Drug

Primary outcomes

  1. Safety

Secondary outcomes

  1. Pharmacokinetics/Pharmacodynamics

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Mar 15, 2007
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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