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
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 April 16, 2014