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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus; Healthy Participants
• Intervention / Treatment: Other: Placebo; Drug: BMS-986165; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986165 Dose 1 oral administration; BMS-986165 therapeutic single dose	Drug: BMS-986165; Specified dose on specified days
Experimental: BMS-986165 Dose 2 oral administration; BMS-986165 supratherapeutic single dose	Drug: BMS-986165; Specified dose on specified days
Active Comparator: Moxifloxacin Dose 3 oral administration; Moxifloxacin positive control single dose	Drug: Moxifloxacin; Specified dose on specified days
Placebo Comparator: Placebo Dose 4 oral administration; Placebo single dose	Other: Placebo; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): September 4, 2018
• Study Completion (Actual): September 4, 2018

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Kinase Inhibitors; Moxifloxacin; BMS-986165
• Other Study ID Numbers: IM011-048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No