Clinical Study to Assess Safety, PK and PD Parameters of CDR132L

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Drug: CDR132L

• Registration Number: NCT04045405
• Lead Sponsor: Cardior Pharmaceuticals GmbH

Brief Summary

This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Detailed Description

Objectives:

Primary

• To assess the safety of one single and one repeated dose of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Secondary • To characterize the pharmacokinetic (PK) profile of CDR132L in patients with stable heart failure of ischemic origin.

Exploratory

• To determine the effect of CDR132L on pharmacodynamic (PD) parameters.

Study Timeline

• Study Start: 2019-06-21
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Primary Completion: 2020-01-31
• Study Completion: 2020-06-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Stable heart failure of ischemic origin

Exclusion Criteria

• Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDR132L	CDR132L	-
Saline	CDR132L	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events [safety and tolerability]	4 months	The incidence and severity of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	4 months	Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)
Time to reach maximum plasma concentration (Tmax)	4 months	Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)
Area under the curve (AUC0-t)	4 months	Pharmacokinetics parameter area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t)
Area under the curve (AUC0-inf)	4 months	Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Blood clearance (CL)	4 months	Pharmacokinetics parameter to determin clearance considering terminal elimination rate
Half life (t1/2)	4 months	Pharmacokinetics parameter to determin half-life rate (t1/2)
Volume of distribution (Vdss)	4 months	Pharmacokinetics parameter

Trial Locations

Locations (1)

Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge; 🇬🇧 London, United Kingdom