Back to resultsAn Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
Primary Purpose
Systemic Lupus Erythematosus, Healthy Participants
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986165
Moxifloxacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- PRA Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
BMS-986165 Dose 1 oral administration
BMS-986165 Dose 2 oral administration
Moxifloxacin Dose 3 oral administration
Placebo Dose 4 oral administration
Arm Description
BMS-986165 therapeutic single dose
BMS-986165 supratherapeutic single dose
Moxifloxacin positive control single dose
Placebo single dose
Outcomes
Primary Outcome Measures
Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
Secondary Outcome Measures
Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG
Heart rate (HR) as determined by 12-lead ECG
QRS as determined by 12-lead ECG
PR as determined by 12-lead ECG
Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG
Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations
Incidence of adverse events (AE)
Incidence of serious adverse events (SAE)
Maximum observed concentration (Cmax) as determined by plasma concentration
Time of maximum observed concentration (Tmax) as determined by plasma concentration
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
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03541564
Brief Title
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
September 4, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Healthy Participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986165 Dose 1 oral administration
Arm Type
Experimental
Arm Description
BMS-986165 therapeutic single dose
Arm Title
BMS-986165 Dose 2 oral administration
Arm Type
Experimental
Arm Description
BMS-986165 supratherapeutic single dose
Arm Title
Moxifloxacin Dose 3 oral administration
Arm Type
Active Comparator
Arm Description
Moxifloxacin positive control single dose
Arm Title
Placebo Dose 4 oral administration
Arm Type
Placebo Comparator
Arm Description
Placebo single dose
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Heart rate (HR) as determined by 12-lead ECG
Time Frame
5 days
Title
QRS as determined by 12-lead ECG
Time Frame
5 days
Title
PR as determined by 12-lead ECG
Time Frame
5 days
Title
Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG
Time Frame
From baseline to 5 days
Title
Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations
Time Frame
Up to 28 days
Title
Incidence of adverse events (AE)
Time Frame
Up to 28 days
Title
Incidence of serious adverse events (SAE)
Time Frame
Up to 28 days
Title
Maximum observed concentration (Cmax) as determined by plasma concentration
Time Frame
5 days
Title
Time of maximum observed concentration (Tmax) as determined by plasma concentration
Time Frame
5 days
Title
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
Title
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
We'll reach out to this number within 24 hrs