Skip to main content
OpenTrials
Completed

NCT Number: NCT03541564

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986165

Drug

Specified dose on specified days

moxifloxacin

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)

    Time frame: From baseline to 5 days

Secondary outcomes

  1. Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG

    Time frame: From baseline to 5 days

  2. Heart rate (HR) as determined by 12-lead ECG

    Time frame: 5 days

  3. QRS as determined by 12-lead ECG

    Time frame: 5 days

  4. PR as determined by 12-lead ECG

    Time frame: 5 days

  5. Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG

    Time frame: From baseline to 5 days

  6. Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations

    Time frame: Up to 28 days

  7. Incidence of adverse events (AE)

    Time frame: Up to 28 days

  8. Incidence of serious adverse events (SAE)

    Time frame: Up to 28 days

  9. Maximum observed concentration (Cmax) as determined by plasma concentration

    Time frame: 5 days

  10. Time of maximum observed concentration (Tmax) as determined by plasma concentration

    Time frame: 5 days

  11. 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

    Time frame: 5 days

  12. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 30, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.