MedTrace Logo

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

NCT05139615 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-11-09

Study results available
· View outcomes & findings →

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).

Conditions

  • Acute Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

APD418

Participants will receive a single dose of APD418 as an intravenous (IV) infusion.

DRUG

APD418

Participants will receive a single dose of APD418 as an IV infusion.

DRUG

Placebo

Participants will receive a single dose of APD418 matching placebo as an IV infusion.

Sponsors & Collaborators

  • Arena is a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-28
Primary Completion
2022-09-19
Completion
2022-09-19
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Greece
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05139615 on ClinicalTrials.gov