Study Evaluating Multiple Oral Doses of PPM-204 in Health... | NCT00448032

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

NCT00448032

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Dec 5, 2007Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Diabetes Mellitus

Interventions

PPM-204

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Mar 14, 2007

First Submission Date that Met QC Criteria

Mar 14, 2007

First Posted Date

Mar 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2007

Last Update Posted Date

Dec 5, 2007Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
PPM-204	Drug

Measure	Description	Time Frame
Safety

Measure	Description	Time Frame
Pharmacokinetics/Pharmacodynamics

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Tokyo		171-0014	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided