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

Completed · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus, Healthy Participants

In brief

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.

Key facts

Study ID

NCT03541564

Run by

Bristol-Myers Squibb

People needed

84

Starts

2018-05-30

Expected to finish

2018-09-04

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PRA Health Sciences — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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