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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT03541564

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

26.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus Healthy Participants	Drug: BMS-986165 Drug: Moxifloxacin Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 30, 2018

Actual Primary Completion Date :

Sep 4, 2018

Actual Study Completion Date :

Sep 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT03541564

Other Study ID Numbers:

IM011-048

First Posted:

May 30, 2018

Last Update Posted:

Jan 27, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Moxifloxacin

BMS-986165

Study Results

No Results Posted as of Jan 27, 2020