Clinical trial NCT03541564: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
timeFrame: From baseline to 5 days
Secondary outcomes:
measure: Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG
timeFrame: From baseline to 5 days
measure: Heart rate (HR) as determined by 12-lead ECG
timeFrame: 5 days
measure: QRS as determined by 12-lead ECG
timeFrame: 5 days
measure: PR as determined by 12-lead ECG
timeFrame: 5 days
measure: Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG
timeFrame: From baseline to 5 days
measure: Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations
timeFrame: Up to 28 days
measure: Incidence of adverse events (AE)
timeFrame: Up to 28 days
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to 28 days
measure: Maximum observed concentration (Cmax) as determined by plasma concentration
timeFrame: 5 days
measure: Time of maximum observed concentration (Tmax) as determined by plasma concentration
timeFrame: 5 days
measure: 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
timeFrame: 5 days
measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration
timeFrame: 5 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: