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. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00721422

Purpose

To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.

Condition	Intervention	Phase
Renal Insufficiency Pharmacokinetics	Drug: PD 0332334	Phase I

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast), [ Time Frame: 5 to 17 days depending on cohort ] [ Designated as safety issue: No ]
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2), [ Time Frame: 5 to 17 days depending on cohort ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs [ Time Frame: 5 to 17 days ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	July 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1-Normal: Experimental	Drug: PD 0332334 50 mg (two 25 mg capsules), single, oral dose
Group 2-Mild: Experimental	Drug: PD 0332334 50 mg (two 25 mg capsules), single, oral dose
Group 3-Moderate: Experimental	Drug: PD 0332334 50 mg (two 25 mg capsules), single, oral dose
Group 4-Severe: Experimental	Drug: PD 0332334 50 mg (two 25 mg capsules), single, oral dose

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers OR subjects with kidney impairment

Exclusion Criteria:

Receiving hemodialysis
clinically significant or unstable medical disease other than kidney disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721422

Locations

United States, California
Pfizer Investigational Site
Cypress, California, United States, 90630
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169

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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5361023
Study First Received:	July 22, 2008
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00721422 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacokinetics of PD 0332334 in subjects with renal insufficiency

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Healthy
Kidney Diseases

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on September 09, 2009