Healthy SubjectsPhase 1NCT00959881
Study Evaluating The Coadministration of Begacestat And Donepezil
A Phase 1 study testing Donepezil and Begacestat in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Donepezil and Begacestat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Cardiac rhythm abnormalities
- Family history of cardiac risk factors
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Donepezil plus placebo, Donepezil, Begacestat
- Keywords
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil plus placeboDrug
Also called Aricept
5- and 10-mg tablets, single dose
DonepezilDrug
Also called Aricept
5- and 10-mg tablets, single dose
BegacestatDrug
Also called GSI-953, WAY-210953, PF-05212362
6 x 50-mg capsules, single dose
| Study group | Role | What they receive |
|---|---|---|
| Donepezil plus placebo | Experimental | Not described Receives: Drug: Donepezil plus placebo |
| Donepezil plus begacestat | Experimental | Not described Receives: Drug: Donepezil; Drug: Begacestat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).
Measured: 5 months
Secondary outcomes (2)
Pharmacokinetic parameters including Cmax, AUC, and t 1/2
Measured: 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959881
- Sponsor's protocol ID
- 3183A1-1106
- Other IDs
- B1941005
- Status last verified
- Apr 2011
- First submitted
- 14 Aug 2009
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00959881
- Acronym / sponsor ID
- 3183A1-1106
- Conditions
- Healthy Subjects
- Keywords
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil plus placebo | Experimental | Drug: Donepezil plus placebo |
| Donepezil plus begacestat | Experimental | Drug: Donepezil, Drug: Begacestat |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Cardiac rhythm abnormalities
- Family history of cardiac risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil plus placeboAlso: Aricept5- and 10-mg tablets, single dose | Drug | Donepezil plus placebo |
| DonepezilAlso: Aricept5- and 10-mg tablets, single dose | Drug | Donepezil plus begacestat |
| BegacestatAlso: GSI-953, WAY-210953, PF-052123626 x 50-mg capsules, single dose | Drug | Donepezil plus begacestat |
Primary outcome
Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).
Time frame: 5 months
2 secondary outcomes
Pharmacokinetic parameters including Cmax, AUC, and t 1/2
Time frame: 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.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donepezil and Begacestat in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG). (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2011.