An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03541564
• Date of registration: 17/05/2018
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
• Scientific title: A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects
• Date of first enrolment: May 30, 2018
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03541564
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Healthy Participants

Intervention(s)

Drug: Moxifloxacin

Drug: BMS-986165

Other: Placebo

Primary Outcome(s)

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(s)

Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG [Time Frame: From baseline to 5 days]

Incidence of adverse events (AE) [Time Frame: Up to 28 days]

QRS as determined by 12-lead ECG [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]

Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations [Time Frame: Up to 28 days]

Heart rate (HR) as determined by 12-lead ECG [Time Frame: 5 days]

Incidence of serious adverse events (SAE) [Time Frame: Up to 28 days]

Time of maximum observed concentration (Tmax) as determined by plasma concentration [Time Frame: 5 days]

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]

Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration [Time Frame: 5 days]

Maximum observed concentration (Cmax) as determined by plasma concentration [Time Frame: 5 days]

PR as determined by 12-lead ECG [Time Frame: 5 days]

Secondary ID(s)

IM011-048

Source(s) of Monetary Support

Please refer to primary and secondary sponsors