BMS-986224 in Healthy Subjects and Chronic Heart Failure Patients
Research type
Research Study
Full title
A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986224 in Healthy Subjects and Chronic Heart Failure Patients with Reduced Ejection Fraction.
IRAS ID
237771
Contact name
David Newby
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-002970-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
Heart failure due to reduced ejection fraction (the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body) accounts for approximately half of heart failure patients.
Current treatments for heart failure cause increased force in heart contractions and output and some cause the constriction of blood vessels, increasing blood pressure. Some of these treatments are potent and can cause harmful side effects.
Research has shown that infusion of a compound, the apelin gene, results in improvement of cardiac output with minimal change in heart rate and to date, no evidence of irregular heartbeat.
This study involves administration of BMS-986224, similar to the apelin gene, which binds to the apelin gene receptor and comparing it to a placebo.
Approximately 256 adult participants; 184 healthy volunteers followed by 72 patients with chronic Heart Failure with reduced ejection fraction will be enrolled in parts A, B and C of the study. The participants will attend one of 20 sites across Europe.
The UK will be running parts B (Japanese healthy volunteers) and C (patients) only. Japanese healthy participants will be randomly assigned in a 3:1 ratio to either placebo or BMS-986224 at multiple ascending doses ranging from 10-90mg daily, to be defined following earlier results. Patients will be randomly assigned in a 2:1 ratio to either 15mg BMS-986224 or placebo, 90mg BMS-986224 or placebo.
The time that the participants will be on the study will be up to 56 days for the healthy volunteers and up to 44 days for patients.
The healthy volunteers will be required to stay at the study site for 19 days and attend two other visits whilst the patients have 5 visits, including two multi-day stays. During these visits the participants will undergo various procedures, administration of study medication and assessments.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0022
Date of REC Opinion
16 Mar 2018
REC opinion
Further Information Favourable Opinion