CClinicalTrials.gg
Sign In
TerminatedNCT03281122Updated Feb 25, 2021

A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction

A Phase 1 interventional study of Placebo and BMS-986224 in Heart Failure, sponsored by Bristol-Myers Squibb. Terminated at 18 sites in 5 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

Why this study was terminated
Business objectives have changed
Phase
Phase 1
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is test the safety and tolerability of BMS-986224 and its effects on the body in healthy subjects and subjects with chronic heart failure with reduced ejection fraction

02

Conditions studied

  • Heart Failure

Browse trials for

03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

Inclusion Criteria:

Healthy Subjects (Part A and B)

  • Healthy subjects, as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
  • Subjects must be willing and able to complete all study-specific procedures and visits
  • Additional criterion for Japanese subjects in Groups BJ1 to BJ3: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese)

Heart Failure Patients (Part C)

  • Left ventricular EF \<45% and >25%, as assessed by cardiac MRI within 3 months of first dose of study drug; or left ventricular EF \<40% and >25% as assessed by echocardiogram at Screening or within 3 months of first dose of study drug; left ventricular EF
  • Heart failure is considered to be stable at the discretion of the Investigator (i.e., no acute cardiovascular [CV] events or hospitalization (including emergency room visits) for CV causes within 3 months of first dose of study drug
  • Regular sinus rhythm at Screening and no history of atrial fibrillation in the past 12 months

Exclusion criteria

Exclusion Criteria:

Healthy Subjects (Part A and B)

  • Major surgery within 4 weeks of (first) study treatment administration
  • Inability to be venipunctured and/or tolerate venous access
  • Subjects who have smoked or used smoking cessation or nicotine containing products (including, but not limited, to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum, varenicline, bupropion) within 6 months of the first dose of study drug

Heart Failure Patients (Part C)

  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
  • Major surgery within 4 weeks of (first) study treatment administration
  • Inability to be venipunctured and/or tolerate venous access

Other protocol defined inclusion/exclusion criteria could apply

04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
199 participants (actual)

Study arms

  • Experimental
    Arm A

    Specified dose on specified days

    Drug: Placebo · Drug: BMS-986224

  • Placebo comparator
    Arm B

    Specified dose on specified days

    Drug: Placebo · Drug: BMS-986224

Interventions

  • DrugPlacebo

    Specified dose on specified days

  • DrugBMS-986224

    Specified dose on specified days

05

What researchers measure

Primary outcomes

  1. Number of Serious Adverse Events (SAEs)

    Time frame: Up to one month

  2. Number of Adverse Events (AEs)

    Time frame: Up to one month

  3. Number of deaths

    Time frame: Up to one month

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to one month

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to one month

  3. Terminal elimination half-life (T-HALF)

    Time frame: Up to one month

  4. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to one month

  5. Area under the plasma concentration-time curve from time zero extrapoloated [AUC(INF)]

    Time frame: Up to one month

  6. Area under the concentration-time curve in one dosing interval [AUC(TAU)]

    Time frame: Up to one month

  7. Accumulation ratio: ratio of Cmax following last dose to Cmax following first dose (ARcmax)

    Time frame: Up to one month

  8. Accumulation ratio: ratio of AUC(TAU) following last dose to AUC(TAU) following first dose (ARtau)

    Time frame: Up to one month

  9. Terminal elimination rate constant (kel)

    Time frame: Up to one month

  10. Apparent oral clearance, calculated as dose/AUC(INF) for single dose or dose/AUC(TAU) for multiple dose

    Time frame: Up to one month

  11. Apparent volume of distribution at terminal phase (Vz/F)

    Time frame: Up to one month

  12. Cumulative urinary excretion (of the unchanged drug) over one dosing interval [Ae(TAU)]

    Time frame: Up to one month

  13. Cumulative urinary excretion (of the unchanged drug) [Aet]

    Time frame: Up to one month

  14. Renal clearance (CLr)

    Time frame: Up to one month

  15. Amount excreted unchanged (%) [UR%]

    Time frame: Up to one month

  16. Ratio of Metabolite Cmax to Parent Cmax, corrected for molecular weight (MR_Cmax)

    Time frame: Up to one month

  17. Ratio of Metabolite AUC(INF) to Parent AUC(INF), corrected for molecular weight

    Time frame: Up to one month

  18. Ratio of Metabolite AUC(0-T) to Parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)]

    Time frame: Up to one month

  19. Ratio of Metabolite AUC(TAU) to Parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)]

    Time frame: Up to one month

  20. Drug-drug interaction (DDI) assessment

    Time frame: Up to one month

06

Study locations

18 sites
  • Vseobecna Fakultni Nemocnice v Praze
    Praha 2, 12808, Czechia
  • Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
    Usti nad Labem, 401 13, Czechia
  • Deventer Ziekenhuis
    Deventer, 7416 SE, Netherlands
  • Universitair Medisch Centrum Groningen
    Groningen, 9713 GZ, Netherlands
  • PRA Health Sciences - Groningen
    Groningen, 9728 NZ, Netherlands
  • Spaarne Gasthuis - Haarlem-Zuid
    Haarlem, 2035 RC, Netherlands
  • D & A Research and Genetics
    Sneek, 8601 ZR, Netherlands
  • Samodzielny Publiczny Szpital Kliniczny Number 4 w Lublinie
    Lublin, 20-954, Poland
  • 4th Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej
    Wroclaw, 50-981, Poland
  • Hospital Universitario Ramon Y Cajal
    Madrid, 28034, Spain
  • Hospital Universitario Fundacion Jimenez Diaz
    Madrid, 28040, Spain
  • Complejo Hospitalario Universitario de Santiago
    Santiago de Compostela, 15706, Spain
  • Hospital Clinico Universitario de Valencia
    Valencia, 46010, Spain
  • Hospital Alvaro Cunqueiro
    Vigo, 36312, Spain
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, B15 2TH, United Kingdom
  • NHS Tayside
    Dundee, DD1 9SY, United Kingdom
  • The University of Edinburgh
    Edinburgh, EH16 4SB, United Kingdom
  • Richmond Pharmacology
    London, United Kingdom
07

References and documents

08

Registry details

Key details

Study ID
NCT03281122
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Sep 22, 2017
Primary completion
Apr 17, 2019
Completion
Apr 17, 2019
Last update
Feb 25, 2021

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Heart Failure→

Other studies from this sponsor

Bristol-Myers Squibb

Start the discussion