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 Ejection Fraction
Novartis Pharmaceuticals
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).
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 admi…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- 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 exclusion criteria: * Acute decompensated heart failu…
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
Locations (3)
- Synergy HealthcareBradenton, Florida
- Nature Coast Clinical Research LLCInverness, Florida
- Jacksonville Center for ClinicalJacksonville, Florida