An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
Phase 1
Completed
- Conditions
- Systemic Lupus ErythematosusHealthy Participants
- Interventions
- Registration Number
- NCT03541564
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BMS-986165 Dose 1 oral administration BMS-986165 BMS-986165 therapeutic single dose BMS-986165 Dose 2 oral administration BMS-986165 BMS-986165 supratherapeutic single dose Placebo Dose 4 oral administration Placebo Placebo single dose Moxifloxacin Dose 3 oral administration Moxifloxacin Moxifloxacin positive control single dose
- Primary Outcome Measures
Name Time Method Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG) From baseline to 5 days
- Secondary Outcome Measures
Name Time Method Incidence of serious adverse events (SAE) Up to 28 days Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG From baseline to 5 days Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations Up to 28 days Heart rate (HR) as determined by 12-lead ECG 5 days Maximum observed concentration (Cmax) as determined by plasma concentration 5 days Time of maximum observed concentration (Tmax) as determined by plasma concentration 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 5 days PR as determined by 12-lead ECG 5 days Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG From baseline to 5 days QRS as determined by 12-lead ECG 5 days Incidence of adverse events (AE) Up to 28 days Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration 5 days
Trial Locations
- Locations (1)
PRA Health Sciences
🇺🇸Lenexa, Kansas, United States