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

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start

Summary

This trial tests APD418, a drug given through an IV, in adults with a type of heart failure where the heart doesn't pump well. The study checks if the drug is safe, how it moves through the body, and if it helps the heart work better. The trial has two parts: one to find the right dose and another to compare different doses.

Eligible Conditions
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Change in Cardiac Index (CI) Measured by Right Heart Catheterization (RHC) From Baseline to End of Intravenous (IV) Infusion at 6 Hours
Secondary study objectives
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 6 Hours (AUC[0-6]) of APD418
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Last Quantifiable Plasma Concentration (AUCLast) of APD418
Part A: Area Under the Plasma Concentration Time Curve From Time Zero up to Infinity (AUC[0-Infinity]) of APD418
+26 more
Other study objectives
Part A: Amount of Unchanged Drug Excreted in Urine During Each Collection Interval From t1 to t2 (Aet1-t2)
Part A: Fraction of Drug Excreted Unchanged (Fe) in Urine
Part A: Total Amount of Unchanged Drug Excreted in Urine Over the Collection Period (Amount Excreted [Ae])

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: APD418 (Part B: Dose Group 1 and 2)Experimental Treatment1 Intervention
Group II: APD418 (Part A: Dose Cohort 1-5)Experimental Treatment1 Intervention
Group III: Placebo (Part A: Cohort 1-5 and Part B)Placebo Group1 Intervention

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,159 Total Patients Enrolled
21 Trials studying Heart Failure
8,046 Patients Enrolled for Heart Failure
Arena is a wholly owned subsidiary of PfizerIndustry Sponsor
10 Previous Clinical Trials
2,549 Total Patients Enrolled
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,780 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,015 Total Patients Enrolled
9 Trials studying Heart Failure
6,623 Patients Enrolled for Heart Failure
Arena CT.gov AdministratorStudy DirectorArena Pharmaceuticals
21 Previous Clinical Trials
4,786 Total Patients Enrolled
~6 spots leftby Dec 2025
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