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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

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.

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

ECG

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.

Eligibility

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

Criteria:

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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