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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: PD 0332334 (Drug); PD 0332334 (Drug); cimetidine (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: 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

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

Primary outcome:

PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)

PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)

Half-life (t1/2) of PD 0332334

Maximum plasma concentration (Cmax) of PD 0332334

Secondary outcome:

Evaluate the incidence, duration and severity of adverse events

Evaluate the discontinuation due to adverse events

Clinical safety labs


Vital signs

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- healthy

- male or female adults

Exclusion Criteria:

- Current or history of clinically significant medical illness

- Smokers

- Illicit drug use

Locations and Contacts

Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2009
Last updated: February 16, 2010

Page last updated: August 23, 2015

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