Evaluating The Effects Of Cimetidine On The Elimination O... | NCT00800280

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

NCT00800280

Sponsor

Pfizer

Status

Terminated

Last Update Posted

Feb 17, 2010Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Generalized Anxiety Disorder

Interventions

PD 0332334
PD 0332334
cimetidine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Please see Detailed Description for termination reason.

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Dec 1, 2008

First Submission Date that Met QC Criteria

Dec 1, 2008

First Posted Date

Dec 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2010

Last Update Posted Date

Feb 17, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single dose PD 0332334	Experimental		Drug: PD 0332334
Single dose PD 0332334 with steady-state cimetidine	Experimental		Drug: PD 0332334 Drug: cimetidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PD 0332334	Drug	Single 300 mg dose of PD 0332334 immediate release capsules administered orally	Single dose PD 0332334

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)		4 to 6 days
PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)		4 to 6 days
Half-life (t1/2) of PD 0332334		4 to 6 days
Maximum plasma concentration (Cmax) of PD 0332334		4 to 6 days

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the incidence, duration and severity of adverse events		4 to 6 days
Evaluate the discontinuation due to adverse events		4 to 6 days
Clinical safety labs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
male or female adults

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		New Haven	Connecticut	06511	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D000098647	Generalized Anxiety Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C583768	imagabalin
D002927	Cimetidine

Ancestor Terms

ID	Term
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D007093	Imidazoles
D001393

Browse Leaves

Not provided

Browse Branches

Not provided