Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Sacubitril, Valsartan, Heart failure, Cardiac Failure, Myocardial Failure, Heart failure with reduced ejection fraction
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).
Detailed description
This is a multi-center, randomized, participant- and investigator- blinded, placebo- controlled crossover study to investigate the safety, tolerability, and pharmacokinetics of HJB647 in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF). The study will consist of approximately 12 participants randomly assigned in a 1:1:1 ratio to one of three 3-day treatment sequences comprised of two doses of HJB647 and placebo. Dosing of the HJB647 and placebo is planned for 3 consecutive days. Participants will be domiciled during study drug administration period for close monitoring with a follow-up in-clinic visit on Day 7. A safety call will be performed on Day 33.
Interventions
DRUGHJB647 low dose
Study drug low dose in capsule form
DRUGHJB647 high dose
Study drug high dose in capsule form
OTHERPlacebo
Placebo control in capsule form
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Participants eligible for inclusion in this study must meet all of the following criteria: * Men and women aged 18 years or older * Stable NYHA functional class II-III * LVEF \<50% * NT-proBNP ≥600 pg/ml if in sinus rhythm or ≥900 pg/ml if in atrial fibrillation at screening * On stable standard of care therapy with sacubitril/valsartan with a dose of at least 49/51 mg BID for at least 4 weeks before screening.
Exclusion criteria
Participants will be deemed ineligible for inclusion if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to 33 days | Number of participants with AEs as a measure of safety and tolerability |
| Number of participants with clinically significant changes in vital signs | Up to 33 days | Number of participants with clinically significant changes in Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Electrocardiogram and hyposensitive events as a measure of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum concentration (Cmax) | Up to 7 days | Maximum concentration (Cmax) of the trial drug in participants' blood |
| Pharmacokinetics: Time to reach maximum plasma concentration (Tmax) | Up to 7 days | Time to require the trial drug to reach its maximum concentration in participants blood |
| Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast) | Up to 7 days | Area under the curve from time zero to the last measurable concentration sampling time |
Countries
Canada, United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed