A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.

Study Overview
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Brief Summary
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To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.

Detailed Description
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Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function. On February 23rd 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, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function

Conditions
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Renal Insufficiency, Pharmacokinetics

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers OR subjects with kidney impairment Exclusion Criteria: Receiving hemodialysis clinically significant or unstable medical disease other than kidney disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1-Normal<br> | Drug: PD 0332334<br>* 50 mg (two 25 mg capsules), single, oral dose<br>* Other names: imagabalin;|
| Experimental: Group 2-Mild<br> | Drug: PD 0332334<br>* 50 mg (two 25 mg capsules), single, oral dose<br>|
| Experimental: Group 3-Moderate<br> | Drug: PD 0332334<br>* 50 mg (two 25 mg capsules), single, oral dose<br>|
| Experimental: Group 4-Severe<br> | Drug: PD 0332334<br>* 50 mg (two 25 mg capsules), single, oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) |  | 1 day | 
| amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96) |  | 5 days | 
| PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast), |  | 5 to 17 days depending on cohort | 
| PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2), |  | 5 to 17 days depending on cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs |  | 5 to 17 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics of PD 0332334 in subjects with renal insufficiency