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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.

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ClinicalTrials.gov Identifier: NCT00721422
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : July 24, 2008
Last Update Posted : February 17, 2010
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Renal Insufficiency Pharmacokinetics Drug: PD 0332334 Phase 1

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : August 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1-Normal Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Other Name: imagabalin
Experimental: Group 2-Mild Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Experimental: Group 3-Moderate Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Experimental: Group 4-Severe Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose


Outcome Measures

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

Secondary Outcome Measures :
  1. Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs [ Time Frame: 5 to 17 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy volunteers OR subjects with kidney impairment

Exclusion Criteria:

  1. Receiving hemodialysis
  2. clinically significant or unstable medical disease other than kidney disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721422


Locations
United States, California
Pfizer Investigational Site
Cypress, California, United States, 90630
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00721422     History of Changes
Other Study ID Numbers: A5361023
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

Keywords provided by Pfizer:
Pharmacokinetics of PD 0332334 in subjects with renal insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases