Alzheimer DiseasePhase 1NCT00979316
Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
A Phase 1 study testing BMS-708163 and Moxifloxacin 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 determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- BMS-708163 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
- Healthy subjects
Who cannot join
- History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
- Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
- Women who are pregnant or breastfeeding
- History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
- History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- Any clinically significant ECG abnormality
- History of seizure disorders
- History of drowning survival
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects
The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).
- Conditions
- Alzheimer Disease
- Being tested
- BMS-708163, Placebo, Moxifloxacin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-708163Drug
Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
BMS-708163Drug
Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
PlaceboDrug
Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
MoxifloxacinDrug
Also called Avelox
Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-708163 (800 mg) | Experimental | Not described Receives: Drug: BMS-708163 |
| BMS-708163 (200 mg) | Experimental | Not described Receives: Drug: BMS-708163 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects
Measured: Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
Secondary outcomes (1)
To assess the effects of BMS-708163 on other ECG endpoints (heart rate [HR], QRS and PR intervals), and changes in waveform morphology
Measured: At -60, -40 and -20 minutes prior to dosing; at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT00979316
- Sponsor's protocol ID
- CN156-020
- Status last verified
- Apr 2010
- First submitted
- 17 Sep 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00979316
- Acronym / sponsor ID
- CN156-020
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Sep 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 this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-708163 (800 mg) | Experimental | Drug: BMS-708163 |
| BMS-708163 (200 mg) | Experimental | Drug: BMS-708163 |
| Placebo | Placebo comparator | Drug: Placebo |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
- Healthy subjects
Key exclusion criteria (8 listed)
- History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
- Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
- Women who are pregnant or breastfeeding
- History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
- History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
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 |
|---|---|---|
| BMS-708163Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days | Drug | BMS-708163 (800 mg) |
| BMS-708163Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days | Drug | BMS-708163 (200 mg) |
| PlaceboOral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days | Drug | Placebo |
| MoxifloxacinAlso: AveloxTablets, Oral, 400 mg, Once on Day 1, approximately 14 days | Drug | Moxifloxacin |
Primary outcome
Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects
Time frame: Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
1 secondary outcome
To assess the effects of BMS-708163 on other ECG endpoints (heart rate [HR], QRS and PR intervals), and changes in waveform morphology
Time frame: At -60, -40 and -20 minutes prior to dosing; at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
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 7 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 BMS-708163 and Moxifloxacin 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 3 inclusion and 8 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 7 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. Some participants in this study may receive a placebo. 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?
Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects (time frame: Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period). 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 7 Jan 2011.