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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.

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00721422
First received: July 22, 2008
Last updated: February 16, 2010
Last verified: February 2010
  Purpose
  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 Intervention Phase
Renal Insufficiency
Pharmacokinetics
Drug: PD 0332334
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs [ Time Frame: 5 to 17 days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00721422     History of Changes
Other Study ID Numbers: A5361023
Study First Received: July 22, 2008
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014