Health TrialsbyHealthPanel

A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction

ConditionHeart Failure With Reduced Ejection Fraction
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • HJB647 low dose

    Drug

    Study drug low dose in capsule form

  • HJB647 high dose

    Drug

    Study drug high dose in capsule form

  • Placebo

    Other intervention

    Placebo control in capsule form

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: HJB647 low doseExperimental treatment 1 intervention
Group C: HJB647 high doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Events (AEs)

Number of participants with AEs as a measure of safety and tolerability

Time frame
Up to 33 days
2

Number of participants with clinically significant changes in vital signs

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

Time frame
Up to 33 days

Secondary outcomes

1

Pharmacokinetics: Maximum concentration (Cmax)

Maximum concentration (Cmax) of the trial drug in participants' blood

Time frame
Up to 7 days
2

Pharmacokinetics: Time to reach maximum plasma concentration (Tmax)

Time to require the trial drug to reach its maximum concentration in participants blood

Time frame
Up to 7 days
3

Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast)

Area under the curve from time zero to the last measurable concentration sampling time

Time frame
Up to 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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