NCT00448032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

March 14, 2007

Last Update Submit

December 3, 2007

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Safety

Secondary Outcomes (1)

  • Pharmacokinetics/Pharmacodynamics

Interventions

PPM-204DRUG

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • History of cardiac, thyroid, muscle, and kidney abnormalities
  • History of NSAID induced bronchospasm or asthma
  • History of any clinically important allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 171-0014, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 15, 2007

Study Start

November 1, 2006

Study Completion

March 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

JP(1)