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.

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Renal Insufficiency; Pharmacokinetics

Treatments: Drug: PD 0332334

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721422

A5361023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers OR subjects with kidney impairment

Exclusion criteria

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

Trial design

16 participants in 4 patient groups

Group 1-Normal

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334

Group 2-Mild

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334

Group 3-Moderate

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334

Group 4-Severe

Experimental group

Treatment:

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334

Drug: PD 0332334