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

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NCT00448032

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Study Location
Tokyo, , 171-0014, Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
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