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

• Status: Completed
• Trial end date: 2018-09-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BMS-986165; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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