Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects
NCT00448032
ABOUT THIS STUDY
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1-800-718-1021
- 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)
- History of cardiac, thyroid, muscle, and kidney abnormalities
- History of NSAID induced bronchospasm or asthma
- History of any clinically important allergies
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects | |||
Official Title ICMJE | A Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Ppm-204 Administered Orally to Healthy Male Japanese Subjects | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Diagnostic | |||
Condition ICMJE | Diabetes Mellitus | |||
Intervention ICMJE | Drug: PPM-204 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | March 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00448032 | |||
Other Study ID Numbers ICMJE | 3180A1-107 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |