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APD418 (Part A: Dose Cohort 1-5) for Heart Failure

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
Awards & highlights

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).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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
4,595 Previous Clinical Trials
12,868,748 Total Patients Enrolled
20 Trials studying Heart Failure
7,203 Patients Enrolled for Heart Failure
Arena is a wholly owned subsidiary of PfizerIndustry Sponsor
10 Previous Clinical Trials
2,623 Total Patients Enrolled
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,854 Total Patients Enrolled
~6 spots leftby Jul 2025