Alzheimer DiseasePhase 1NCT01042314
Drug-Drug Interaction Study With Aricept® (Donepezil)
A Phase 1 study testing Donepezil and BMS-708163 in people with Alzheimer Disease, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donepezil and BMS-708163
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2010
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy men and postmenopausal women
Who cannot join
- Medical History and Concurrent Diseases
- Gastrointestinal disease
- Gastrointestinal bleeding disorders
- History of peptic ulcer disease
- History of cholecystectomy
- History of seizure disorder
Show all 11Show fewer
- History of asthma
- History of Chronic Obstructive Pulmonary Disease
- History of cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
- Inability to tolerate oral medication
- Inability to be venipunctured and/or tolerate venous access
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International - Baltimore Epcu
Baltimore, Maryland, 21225
About this study
Official title: A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects
The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time
- Conditions
- Alzheimer Disease
- Being tested
- Donepezil, BMS-708163
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aricept®
Tablets, Oral, 5 mg, Once Daily, Days 1-28
BMS-708163Drug
Capsule, Oral, 125 mg, Once Daily, Days 15-28
| Study group | Role | What they receive |
|---|---|---|
| Donepezil and BMS-708163 | Experimental | Not described Receives: Drug: Donepezil; Drug: BMS-708163 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28
Measured: Days 14 and 28
Secondary outcomes (1)
Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs
Measured: Days 7, 14, 21, 29 and study discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042314
- Sponsor's protocol ID
- CN156-008
- Status last verified
- Apr 2010
- First submitted
- 22 Dec 2009
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01042314
- Acronym / sponsor ID
- CN156-008
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Jan 2010 (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.
The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donepezil and BMS-708163 | Experimental | Drug: Donepezil, Drug: BMS-708163 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and postmenopausal women
Key exclusion criteria (11 listed)
- Medical History and Concurrent Diseases
- Gastrointestinal disease
- Gastrointestinal bleeding disorders
- History of peptic ulcer disease
- History of cholecystectomy
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 |
|---|---|---|
| DonepezilAlso: Aricept®Tablets, Oral, 5 mg, Once Daily, Days 1-28 | Drug | Donepezil and BMS-708163 |
| BMS-708163Capsule, Oral, 125 mg, Once Daily, Days 15-28 | Drug | Donepezil and BMS-708163 |
Primary outcome
Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28
Time frame: Days 14 and 28
1 secondary outcome
Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs
Time frame: Days 7, 14, 21, 29 and study discharge
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 25 Jan 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-708163 in people with Alzheimer Disease, run by Bristol-Myers Squibb 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 1 inclusion and 11 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 25 Jan 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?
Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28 (time frame: Days 14 and 28). 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 25 Jan 2011.