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

NCT03281122 | Terminated Phase 1 FDA Drug

• 1 other identifier: CV016-007
• Study Type: interventional
• Target: 199
• Locations: 5 countries
• Sites: 18

Brief 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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Number of Serious Adverse Events (SAEs)

  Up to one month

• Number of Adverse Events (AEs)

  Up to one month

• Number of deaths

  Up to one month

Secondary Outcomes (20)

• Maximum observed plasma concentration (Cmax)

  Up to one month

• Time of maximum observed plasma concentration (Tmax)

  Up to one month

• Terminal elimination half-life (T-HALF)

  Up to one month

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

  Up to one month

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

  Up to one month

Study Arms (2)

Arm A

EXPERIMENTAL

Specified dose on specified days

Drug: Placebo; Drug: BMS-986224

Arm B

PLACEBO COMPARATOR

Specified dose on specified days

Drug: Placebo; Drug: BMS-986224

Interventions

Placebo DRUG

Specified dose on specified days

Arm A; Arm B

BMS-986224 DRUG

Specified dose on specified days

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (18)

Vseobecna Fakultni Nemocnice v Praze

Prague, 12808, Czechia

Location

Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, 401 13, Czechia

Location

Deventer Ziekenhuis

Deventer, 7416 SE, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

PRA Health Sciences - Groningen

Groningen, 9728 NZ, Netherlands

Location

Spaarne Gasthuis - Haarlem-Zuid

Haarlem, 2035 RC, Netherlands

Location

D & A Research and Genetics

Sneek, 8601 ZR, Netherlands

Location

Samodzielny Publiczny Szpital Kliniczny Number 4 w Lublinie

Lublin, 20-954, Poland

Location

4th Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Wroclaw, 50-981, Poland

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

The University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Richmond Pharmacology

London, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: September 22, 2017
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

PL (2); GB (4); CZ (2); ES (5); NL (5)