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.

NCT ID: NCT00721422

Last Updated: 2010-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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

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Renal Insufficiency Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Group 1-Normal

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

50 mg (two 25 mg capsules), single, oral dose

Group 2-Mild

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

50 mg (two 25 mg capsules), single, oral dose

Group 3-Moderate

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

50 mg (two 25 mg capsules), single, oral dose

Group 4-Severe

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

50 mg (two 25 mg capsules), single, oral dose

Interventions

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PD 0332334

50 mg (two 25 mg capsules), single, oral dose

Intervention Type DRUG

PD 0332334

50 mg (two 25 mg capsules), single, oral dose

Intervention Type DRUG

PD 0332334

50 mg (two 25 mg capsules), single, oral dose

Intervention Type DRUG

PD 0332334

50 mg (two 25 mg capsules), single, oral dose

Intervention Type DRUG

Other Intervention Names

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imagabalin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cypress, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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A5361023

Identifier Type: -

Identifier Source: org_study_id

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