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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants; Systemic Lupus Erythematosus

Treatments: Drug: BMS-986165; Drug: Moxifloxacin; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03541564

IM011-048

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups, including a placebo group

BMS-986165 Dose 1 oral administration

Experimental group

Description:

BMS-986165 therapeutic single dose

Treatment:

Drug: BMS-986165

BMS-986165 Dose 2 oral administration

Experimental group

Description:

BMS-986165 supratherapeutic single dose

Treatment:

Drug: BMS-986165

Moxifloxacin Dose 3 oral administration

Active Comparator group

Description:

Moxifloxacin positive control single dose

Treatment:

Drug: Moxifloxacin

Placebo Dose 4 oral administration

Placebo Comparator group

Description:

Placebo single dose

Treatment:

Other: Placebo