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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00730145
First received: August 6, 2008
Last updated: February 16, 2010
Last verified: February 2010
  Purpose
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00730145

Locations
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
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: NCT00730145     History of Changes
Other Study ID Numbers: A5361032
Study First Received: August 6, 2008
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetics, PD-0332334, hemodialysis, renal dialysis

ClinicalTrials.gov processed this record on October 01, 2014