Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts 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 failure within 3 months prior to screening - SBP <105 mmHg at screening or baseline. - Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening - Hemodynamically significant mitral and/or aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to LV dilation at screening - eGFR <45 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula - BMI >40 kg/m2 - Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products - Women of childbearing potential Further eligibility criteria might apply in alignment with the trial protocol.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Taken by mouth as capsules
  • Other: Placebo
    Placebo control in capsule form
Experimental
HJB647 low dose
Taken by mouth as capsule
  • Drug: HJB647 low dose
    Study drug low dose in capsule form
Experimental
HJB647 high dose
Taken by mouth as capsule
  • Drug: HJB647 high dose
    Study drug high dose in capsule form

Recruiting Locations

Synergy Healthcare
Bradenton, Florida 34208
Contact:
Shannon Stickels
sstickels@synergyhealthcorp.com

Nature Coast Clinical Research LLC
Inverness, Florida 34452
Contact:
Jill Barnett
+1 352 341 2100
jbarnett@flourishresearch.com

Jacksonville Center for Clinical
Jacksonville, Florida 32216
Contact:
Sara Villotti
+1 904 730 0101
svillotti@encoredocs.com

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.