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.

This study has been terminated.

(Please see Detailed Description for termination reason.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00721422

First received: July 22, 2008

Last updated: February 16, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 22, 2008

Last Updated Date

February 16, 2010

Start Date ^ICMJE

August 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00721422 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

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

Brief Summary

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Renal Insufficiency
Pharmacokinetics

Intervention ^ICMJE

Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose

Other Name: imagabalin
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose

Study Arm (s)

Experimental: Group 1-Normal
Intervention: Drug: PD 0332334
Experimental: Group 2-Mild
Intervention: Drug: PD 0332334
Experimental: Group 3-Moderate
Intervention: Drug: PD 0332334
Experimental: Group 4-Severe
Intervention: Drug: PD 0332334

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteers OR subjects with kidney impairment

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00721422

Other Study ID Numbers ^ICMJE

A5361023

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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