Study Evaluating The Coadministration of Begacestat And D... | NCT00959881

Studies
Study Evaluating The Coadministration of Begacestat And Donepezil

NCT00959881

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Apr 4, 2011Estimated

Enrollment

47Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

Donepezil plus placebo
Donepezil
Begacestat

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

ID	Type	Description	Link
B1941005

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Aug 14, 2009

First Submission Date that Met QC Criteria

Aug 14, 2009

First Posted Date

Aug 17, 2009Estimated

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

Apr 1, 2011

Last Update Posted Date

Apr 4, 2011Estimated

Name	Class
Pfizer	INDUSTRY

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

This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.

Detailed Description

Not provided

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

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Donepezil plus placebo	Experimental		Drug: Donepezil plus placebo
Donepezil plus begacestat	Experimental		Drug: Donepezil Drug: Begacestat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Donepezil plus placebo	Drug	5- and 10-mg tablets, single dose	Donepezil plus placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).		5 months

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters including Cmax, AUC, and t 1/2		5 months
Safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events.		5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Men and women of non-childbearing potential
Non smoker or smoker of <10 cigarettes per day and able to refrain from smoking during study
18-50 years old

Exclusion Criteria:

Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Cardiac rhythm abnormalities
Family history of cardiac risk factors

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 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		Overland Park	Kansas	66211	United States

References Module

Citations

Not provided

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic