Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

NCT ID: NCT00800280

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Detailed Description

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Detailed Description:

Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.

On February 18th 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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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Single dose PD 0332334

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Single 300 mg dose of PD 0332334 immediate release capsules administered orally

Single dose PD 0332334 with steady-state cimetidine

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.

cimetidine

Intervention Type DRUG

600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

Interventions

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PD 0332334

Single 300 mg dose of PD 0332334 immediate release capsules administered orally

Intervention Type DRUG

PD 0332334

Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.

Intervention Type DRUG

cimetidine

600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

Intervention Type DRUG

Other Intervention Names

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imagabalin

Eligibility Criteria

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Inclusion Criteria

* healthy
* male or female adults

Exclusion Criteria

* Current or history of clinically significant medical illness
* Smokers
* Illicit drug use
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A5361030

Identifier Type: -

Identifier Source: org_study_id

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