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

Heart Failure Clinical Trial

Official title:

Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess Safety, PK and PD Parameters of CDR132L in Patients With Stable Heart Failure of Ischemic Origin (NYHA 1- 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04045405
• Other study ID #: CDR132L-FIH01
• Secondary ID: 2019-001291-10
• Status: Completed
• Phase: Phase 1
• Start date: June 21, 2019
• Est. completion date: June 26, 2020

Study information

• Verified date: March 2022
• Source: Cardior Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 26, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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),

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• CDR132L
i.v. administration

Locations

Country	Name	City	State
United Kingdom	Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge	London

Sponsors (1)

Lead Sponsor	Collaborator
Cardior Pharmaceuticals GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events [safety and tolerability]	The incidence and severity of treatment-emergent adverse events (TEAEs)	4 months
Secondary	Maximum plasma concentration (Cmax)	Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)	4 months
Secondary	Time to reach maximum plasma concentration (Tmax)	Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)	4 months
Secondary	Area under the curve (AUC0-t)	Pharmacokinetics parameter area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t)	4 months
Secondary	Area under the curve (AUC0-inf)	Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)	4 months
Secondary	Blood clearance (CL)	Pharmacokinetics parameter to determin clearance considering terminal elimination rate	4 months
Secondary	Half life (t1/2)	Pharmacokinetics parameter to determin half-life rate (t1/2)	4 months
Secondary	Volume of distribution (Vdss)	Pharmacokinetics parameter	4 months