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

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541564
• Other study ID #: IM011-048
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2018
• Est. completion date: September 4, 2018

Study information

• Verified date: January 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 4, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• BMS-986165
Specified dose on specified days
• Moxifloxacin
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)		From baseline to 5 days
Secondary	Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG		From baseline to 5 days
Secondary	Heart rate (HR) as determined by 12-lead ECG		5 days
Secondary	QRS as determined by 12-lead ECG		5 days
Secondary	PR as determined by 12-lead ECG		5 days
Secondary	Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG		From baseline to 5 days
Secondary	Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations		Up to 28 days
Secondary	Incidence of adverse events (AE)		Up to 28 days
Secondary	Incidence of serious adverse events (SAE)		Up to 28 days
Secondary	Maximum observed concentration (Cmax) as determined by plasma concentration		5 days
Secondary	Time of maximum observed concentration (Tmax) as determined by plasma concentration		5 days
Secondary	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		5 days
Secondary	Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration		5 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form