NCT00721422

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.

A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	PD 0332334	50 mg (two 25 mg capsules), single, oral dose
DRUG	PD 0332334	50 mg (two 25 mg capsules), single, oral dose
DRUG	PD 0332334	50 mg (two 25 mg capsules), single, oral dose
DRUG	PD 0332334	50 mg (two 25 mg capsules), single, oral dose

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-07-24
• Last updated: 2010-02-17

Locations

2 sites across 1 country: United States