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

This study has been terminated.

(Please see Detailed Description for termination reason.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00800280

First received: December 1, 2008

Last updated: February 16, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2008

Last Updated Date

February 16, 2010

Start Date ^ICMJE

January 2009

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf) [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
PD 0332334 AUC from 0 to last quantifiable concentration (AUClast) [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
Half-life (t1/2) of PD 0332334 [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
Maximum plasma concentration (Cmax) of PD 0332334 [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00800280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the incidence, duration and severity of adverse events [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
Evaluate the discontinuation due to adverse events [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
Clinical safety labs [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
ECG [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: 4 to 6 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

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

Official Title ^ICMJE

A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Generalized Anxiety Disorder

Intervention ^ICMJE

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

Other Name: imagabalin
Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
Drug: cimetidine
600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

Study Arm (s)

Experimental: Single dose PD 0332334
Intervention: Drug: PD 0332334
Experimental: Single dose PD 0332334 with steady-state cimetidine
Interventions:
- Drug: PD 0332334
- Drug: cimetidine

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
male or female adults

Exclusion Criteria:

Current or history of clinically significant medical illness
Smokers
Illicit drug use

Gender

Both

Ages

18 Years to 55 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

NCT00800280

Other Study ID Numbers ^ICMJE

A5361030

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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