A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and effect on cardiac function of intravenous APD418 in adult participants with heart failure with reduced ejection fraction (HFrEF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals

Criteria

Inclusion Criteria:

• Advanced chronic Heart Failure with Reduced Ejection Fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 35% at Screening, including documented history of HFrEF (LVEF ≤ 35%) for at least 4 months prior to Screening

• New York Heart Association Class II-IV

• Cardiac index ≤ 2.5 liters per minute per square meter (L/min/m^2) and pulmonary capillary wedge pressure ≥ 15 millimeters of mercury (mm Hg) at Day 1

• Body mass index 18.0 to 37.0 kilograms per square meter (kg/m^2), inclusive

Exclusion Criteria:

• Hemodynamically unstable at Day 1 or in the opinion of the Investigator likely to progress to being hemodynamically unstable during the course of the study

• Treated with carvedilol in general (Part A) or at a dose higher than a total of 25 milligrams per day (Part B) any time within 14 days of Day 1 through the end of the in-clinic observation Post-dose Period.

• Receiving any mechanical (respiratory or circulatory) or renal support therapy at Screening or Day 1

• Systolic Blood Pressure ≤ 90 millimeter of mercury (mm Hg) or ≥ 160 mm Hg, or Heart Rate < 50 beats per minute (bpm) or > 110 bpm, at Screening or Day 1

• Recently treated with inotropic, vasoactive or intravenous diuretic therapy, or expected to require such therapy with these drugs any time from Day 1 through the end of study conduct.