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

Phase 1

Completed

• Conditions: Renal Dialysis; Pharmacokinetics
• Interventions: Drug: PD-0332334

• Registration Number: NCT00730145
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Assess the elimination of PD-0332334 from the blood with hemodialysis

Study Timeline

• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Study Start: 2008-09
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-16
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-0332334	PD-0332334	-

Primary Outcome Measures

Name	Time	Method
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	0 to 8 days
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	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).	0 to 8 days

Secondary Outcome Measures

Name	Time	Method
Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.	0 to 8 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Orlando, Florida, United States