A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

NCT ID: NCT00730145

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-01-31

Brief Summary

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1. Quantify how much PD-0332334 is removed from the blood with hemodialysis
2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.

Detailed Description

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Assess the elimination of PD-0332334 from the blood with hemodialysis

Conditions

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Renal Dialysis Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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PD-0332334

Group Type EXPERIMENTAL

PD-0332334

Intervention Type DRUG

A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject

Interventions

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PD-0332334

A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject

Intervention Type DRUG

Other Intervention Names

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imagabalin

Eligibility Criteria

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Inclusion Criteria

* Patients receiving regular hemodialysis
* Male or female patients 18 to 65 years

Exclusion Criteria

* Severe heart failure
* Renal transplant or renal allograft
* Illicit drug use (with the exception of prescribed sedatives)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Orlando, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A5361032

Identifier Type: -

Identifier Source: org_study_id

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