Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

Study Overview
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Brief Summary
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To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.

Detailed Description
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Detailed Description: Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration. On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Official Title
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A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: Metformin
* Drug: Metformin
* Drug: PD 0332334
* Drug: PD 0332334


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonsmokers Male or female adults Exclusion Criteria: Current or history of significant medical illness Smokers Illicit drug use

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults | Drug: Metformin<br>* 225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release<br>* Other names: imagabalin;Drug: Metformin<br>* Single, oral, 500 mg of metformin immediate release<br>|
| Other: Cohort 2<br>This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults | Drug: PD 0332334<br>* 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<br>Drug: PD 0332334<br>* Single, oral, 300 mg dose of PD 0332334 immediate release formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metformin, PD 0332334, organic cation transporter, OCT2, pharmacokinetics