Study Evaluating The Coadministration of Begacestat And Donepezil

Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959881

Enrollment

Registered

2009-08-17

Start date

2009-08-31

Completion date

2009-11-30

Last updated

2011-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Alzheimer Disease

Brief summary

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

Interventions

DRUGDonepezil plus placebo

5- and 10-mg tablets, single dose

DRUGDonepezil

5- and 10-mg tablets, single dose

DRUGBegacestat

6 x 50-mg capsules, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026