Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Subcutaneous Doses Of PF-04603629 In Type 2 Diabetic Adult Subjects
1 other identifier
interventional
71
1 country
2
Brief Summary
PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus-type-2
Started Aug 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedJuly 31, 2009
March 1, 2008
March 12, 2008
July 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM.
1 week per dose group
To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
1 week per dose group
To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
1 week per dose group
Secondary Outcomes (1)
No secondary outcomes listed in the protocol.
Study Arms (2)
Placebo
PLACEBO COMPARATORPF-04603629
EXPERIMENTALInterventions
Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Hb A1c lower or equal to 11%
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Evidence of diabetic complications with significant end-organ damage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Phoenix, Arizona, 85013, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 19, 2008
Study Start
August 1, 2007
Study Completion
February 1, 2008
Last Updated
July 31, 2009
Record last verified: 2008-03