An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
| Status: | Completed |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 9/30/2018 |
| Start Date: | May 30, 2018 |
| End Date: | September 4, 2018 |
A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects
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.
in order to study the effects it has on electrocardiogram results.
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
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