A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.

Phase 1

Terminated

• Conditions: Renal Insufficiency; Pharmacokinetics
• Interventions: Drug: PD 0332334

• Registration Number: NCT00721422
• Lead Sponsor: Pfizer

Brief Summary

1. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.

2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.

Detailed Description

Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.

On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Study Timeline

• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Study Start: 2008-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-16
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Healthy volunteers OR subjects with kidney impairment

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Exclusion Criteria

1. Receiving hemodialysis
2. clinically significant or unstable medical disease other than kidney disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1-Normal	PD 0332334	-
Group 2-Mild	PD 0332334	-
Group 3-Moderate	PD 0332334	-
Group 4-Severe	PD 0332334	-

Primary Outcome Measures

Name	Time	Method
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)	1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)	5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),	5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),	5 to 17 days depending on cohort

Secondary Outcome Measures

Name	Time	Method
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs	5 to 17 days

Trial Locations

Locations (1)

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