A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HJB647 low dose, HJB647 high dose, Placebo.
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug HJB647 low dose
Study drug low dose in capsule form - Drug HJB647 high dose
Study drug high dose in capsule form - Other Placebo
Placebo control in capsule form
Primary outcome measures
- Number of participants with Adverse Events (AEs) [Time frame: Up to 33 days]
- Number of participants with clinically significant changes in vital signs [Time frame: Up to 33 days]
Secondary outcome measures (3)
- Pharmacokinetics: Maximum concentration (Cmax) [Time frame: Up to 7 days]
- Pharmacokinetics: Time to reach maximum plasma concentration (Tmax) [Time frame: Up to 7 days]
- Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast) [Time frame: Up to 7 days]
Eligibility criteria
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 <30 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Synergy Healthcare — Bradenton
- Nature Coast Clinical Research LLC — Inverness
- Jacksonville Center for Clinical — Jacksonville
Canada · 1 center
- Novartis Investigative Site — Montreal
Identifiers
NCT: NCT07465653 · CHJB647A12103