Alzheimer DiseasePhase 1NCT01039194
Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)
A Phase 1 study testing galantamine and BMS-708163 in people with Alzheimer Disease, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of the study is to find out if the plasma concentration of galantamine extended release 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?
- galantamine 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
- Gastrointestinal disorders
- Bleeding disorders
- Peptic ulcer disease
- Cholecystectomy
- Seizure disorder
- Asthma
Show all 11Show fewer
- Chronic obstructive pulmonary disease
- Urinary tract obstruction
- 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 Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects
The purpose of the study is to find out if the plasma concentration of galantamine extended release is changed when BMS-708163 is administered at the same time.
- Conditions
- Alzheimer Disease
- Being tested
- galantamine, 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.
galantamineDrug
Also called Razadyne ER ™
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
galantamineDrug
Also called Razadyne ER ™
Capsule, Oral, 16 mg (ER), once daily, Days 8-24
BMS-708163Drug
Capsule, Oral, 125 mg, once daily, Days 15-24
| Study group | Role | What they receive |
|---|---|---|
| galantamine 8 mg (ER) | Active comparator | Not described Receives: Drug: galantamine |
| galantamine 16 mg (ER) | Active comparator | Not described Receives: Drug: galantamine |
| BMS-708163 | Active comparator | Not described Receives: Drug: BMS-708163 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)
Measured: Study Days 14 & 24
Secondary outcomes (1)
Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Measured: Study Days 7, 14, 18, 25 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 posted24 Dec 2009 (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
- NCT01039194
- Sponsor's protocol ID
- CN156-009
- Status last verified
- Feb 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 Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01039194
- Acronym / sponsor ID
- CN156-009
- 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
- 24 Dec 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.
The purpose of the study is to find out if the plasma concentration of galantamine extended release 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
- 3
| Arm | Type | Receives |
|---|---|---|
| galantamine 8 mg (ER) | Active comparator | Drug: galantamine |
| galantamine 16 mg (ER) | Active comparator | Drug: galantamine |
| BMS-708163 | Active comparator | 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)
- Gastrointestinal disorders
- Bleeding disorders
- Peptic ulcer disease
- Cholecystectomy
- Seizure disorder
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 |
|---|---|---|
| galantamineAlso: Razadyne ER ™Capsule, Oral, 8 mg (ER), once daily, Days 1-7 | Drug | galantamine 8 mg (ER) |
| galantamineAlso: Razadyne ER ™Capsule, Oral, 16 mg (ER), once daily, Days 8-24 | Drug | galantamine 16 mg (ER) |
| BMS-708163Capsule, Oral, 125 mg, once daily, Days 15-24 | Drug | BMS-708163 |
Primary outcome
Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)
Time frame: Study Days 14 & 24
1 secondary outcome
Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Time frame: Study Days 7, 14, 18, 25 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.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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 galantamine 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?
Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24) (time frame: Study Days 14 & 24). 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.