Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

Study Overview
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Brief Summary
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The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Detailed Description
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Detailed Description: Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334. 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 Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects

Conditions
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Generalized Anxiety Disorder

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male or female adults Exclusion Criteria: Current or history of clinically significant medical illness Smokers Illicit drug use

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Single dose PD 0332334<br> | Drug: PD 0332334<br>* Single 300 mg dose of PD 0332334 immediate release capsules administered orally<br>* Other names: imagabalin;|
| Experimental: Single dose PD 0332334 with steady-state cimetidine<br> | Drug: PD 0332334<br>* Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.<br>Drug: cimetidine<br>* 600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf) |  | 4 to 6 days | 
| PD 0332334 AUC from 0 to last quantifiable concentration (AUClast) |  | 4 to 6 days | 
| Half-life (t1/2) of PD 0332334 |  | 4 to 6 days | 
| Maximum plasma concentration (Cmax) of PD 0332334 |  | 4 to 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence, duration and severity of adverse events |  | 4 to 6 days | 
| Evaluate the discontinuation due to adverse events |  | 4 to 6 days | 
| Clinical safety labs |  | 4 to 6 days | 
| ECG |  | 4 to 6 days | 
| Vital signs |  | 4 to 6 days | 

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