Systemic Lupus ErythematosusPhase 1NCT03541564
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
A Phase 1 study testing BMS-986165 and Moxifloxacin in people with Systemic Lupus Erythematosus and Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Healthy Participants
- What is being tested?
- BMS-986165 and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 4 Sep 2018
- 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 as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.732 m2
Who cannot join
- Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease
- A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects
This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.
- Conditions
- Systemic Lupus Erythematosus, Healthy Participants
- Being tested
- BMS-986165, Moxifloxacin, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986165Drug
Specified dose on specified days
MoxifloxacinDrug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986165 Dose 1 oral administration | Experimental | BMS-986165 therapeutic single dose Receives: Drug: BMS-986165 |
| BMS-986165 Dose 2 oral administration | Experimental | BMS-986165 supratherapeutic single dose Receives: Drug: BMS-986165 |
| Moxifloxacin Dose 3 oral administration | Active comparator | Moxifloxacin positive control single dose Receives: Drug: Moxifloxacin |
| Placebo Dose 4 oral administration | Placebo comparator | Placebo single dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
Measured: From baseline to 5 days
Secondary outcomes (12)
Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG
Measured: From baseline to 5 days
Heart rate (HR) as determined by 12-lead ECG
Measured: 5 days
QRS as determined by 12-lead ECG
Measured: 5 days
PR as determined by 12-lead ECG
Measured: 5 days
Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG
Measured: From baseline to 5 days
Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations
Measured: Up to 28 days
Incidence of adverse events (AE)
Measured: Up to 28 days
Incidence of serious adverse events (SAE)
Measured: Up to 28 days
Maximum observed concentration (Cmax) as determined by plasma concentration
Measured: 5 days
Time of maximum observed concentration (Tmax) as determined by plasma concentration
Measured: 5 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] as determined by plasma concentration
Measured: 5 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start30 May 2018
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541564
- Sponsor's protocol ID
- IM011-048
- Status last verified
- Jan 2020
- First submitted
- 17 May 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03541564
- Acronym / sponsor ID
- IM011-048
- Conditions
- Systemic Lupus Erythematosus, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 30 May 2018 (actual)
- 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 is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-986165 Dose 1 oral administration | Experimental | Drug: BMS-986165BMS-986165 therapeutic single dose |
| BMS-986165 Dose 2 oral administration | Experimental | Drug: BMS-986165BMS-986165 supratherapeutic single dose |
| Moxifloxacin Dose 3 oral administration | Active comparator | Drug: MoxifloxacinMoxifloxacin positive control single dose |
| Placebo Dose 4 oral administration | Placebo comparator | Other: PlaceboPlacebo single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.732 m2
Key exclusion criteria (4 listed)
- Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease
- A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- Other protocol defined inclusion/exclusion criteria could apply
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-986165Specified dose on specified days | Drug | BMS-986165 Dose 1 oral administration, BMS-986165 Dose 2 oral administration |
| MoxifloxacinSpecified dose on specified days | Drug | Moxifloxacin Dose 3 oral administration |
| PlaceboSpecified dose on specified days | Other | Placebo Dose 4 oral administration |
Primary outcome
Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
Time frame: From baseline to 5 days
12 secondary outcomes
Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG
Time frame: From baseline to 5 days
Heart rate (HR) as determined by 12-lead ECG
Time frame: 5 days
QRS as determined by 12-lead ECG
Time frame: 5 days
PR as determined by 12-lead ECG
Time frame: 5 days
Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG
Time frame: From baseline to 5 days
Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations
Time frame: Up to 28 days
Incidence of adverse events (AE)
Time frame: Up to 28 days
Incidence of serious adverse events (SAE)
Time frame: Up to 28 days
Maximum observed concentration (Cmax) as determined by plasma concentration
Time frame: 5 days
Time of maximum observed concentration (Tmax) as determined by plasma concentration
Time frame: 5 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] as determined by plasma concentration
Time frame: 5 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration
Time frame: 5 days
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 27 Jan 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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-986165 and Moxifloxacin in people with Systemic Lupus Erythematosus and Healthy Participants, 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 4 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 27 Jan 2020. 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?
Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG) (time frame: From baseline to 5 days). 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 27 Jan 2020.