Study Stopped
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Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time
A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
- 1.To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
- 2.To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
- 3.To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2009
Shorter than P25 for phase_1
1 active site
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
First Submitted
Initial submission to the registry
December 15, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 17, 2010
February 1, 2010
1 month
December 15, 2008
February 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
Days 1 through 7
Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Days 1 through 7
Metformin and PD 0332334 half-life (t1/2)
Days 1 through 7
Metformin and PD 0332334 maximum plasma concentration
Days 1 through 7
Secondary Outcomes (5)
Clinical safety laboratories
Days 1 through 7
Incidence, duration and severity of adverse events when study medications administered alone and concurrently
Days 1 through 7
Discontinuation due to adverse events when study medications administered alone and concurrently
Days 1 through 7
12-lead ECGs
Days 1 through 7
Vital signs
Days 1 through 7
Study Arms (2)
Cohort 1
OTHERThis is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
Cohort 2
OTHERThis is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
Interventions
225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
Eligibility Criteria
You may qualify if:
- Nonsmokers
- Male or female adults
You may not qualify if:
- Current or history of significant medical illness
- Smokers
- Illicit drug use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 15, 2008
First Posted
December 17, 2008
Study Start
January 1, 2009
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
February 17, 2010
Record last verified: 2010-02