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A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 6, 2008
Last updated: February 16, 2010
Last verified: February 2010
  1. Quantify how much PD-0332334 is removed from the blood with hemodialysis
  2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
  3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.

Condition Intervention Phase
Renal Dialysis Pharmacokinetics Drug: PD-0332334 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis [ Time Frame: 0 to 8 days ]
  • Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis [ Time Frame: 0 to 8 days ]
  • Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast). [ Time Frame: 0 to 8 days ]

Secondary Outcome Measures:
  • Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs. [ Time Frame: 0 to 8 days ]

Enrollment: 8
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD-0332334 Drug: PD-0332334
A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject
Other Name: imagabalin

Detailed Description:
Assess the elimination of PD-0332334 from the blood with hemodialysis

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients receiving regular hemodialysis
  • Male or female patients 18 to 65 years

Exclusion Criteria:

  • Severe heart failure
  • Renal transplant or renal allograft
  • Illicit drug use (with the exception of prescribed sedatives)
  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 identifier: NCT00730145

United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00730145     History of Changes
Other Study ID Numbers: A5361032
Study First Received: August 6, 2008
Last Updated: February 16, 2010

Keywords provided by Pfizer:
pharmacokinetics, PD-0332334, hemodialysis, renal dialysis processed this record on August 18, 2017