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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00800280
• Other study ID #: A5361030
• Status: Terminated
• Phase: Phase 1
• First received: December 1, 2008
• Last updated: February 16, 2010
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy

• male or female adults

Exclusion Criteria:

• Current or history of clinically significant medical illness

• Smokers

• Illicit drug use

Study Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)		4 to 6 days	No
Primary	PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)		4 to 6 days	No
Primary	Half-life (t1/2) of PD 0332334		4 to 6 days	No
Primary	Maximum plasma concentration (Cmax) of PD 0332334		4 to 6 days	No
Secondary	Evaluate the incidence, duration and severity of adverse events		4 to 6 days	Yes
Secondary	Evaluate the discontinuation due to adverse events		4 to 6 days	Yes
Secondary	Clinical safety labs		4 to 6 days	Yes
Secondary	ECG		4 to 6 days	Yes
Secondary	Vital signs		4 to 6 days	Yes

External Links

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