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

History of Changes

Purpose

Quantify how much PD-0332334 is removed from the blood with hemodialysis
Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
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:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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 May 16, 2013

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