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

Cardior Pharmaceuticals GmbH28 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure

Interventions

CDR132LDRUG

i.v. administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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),

Locations (1)

Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge

London, United Kingdom

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events [safety and tolerability]

The incidence and severity of treatment-emergent adverse events (TEAEs)

Time frame: 4 months

Secondary Outcomes

Maximum plasma concentration (Cmax)

Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)

Time frame: 4 months

Time to reach maximum plasma concentration (Tmax)

Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)

Time frame: 4 months

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)

Time frame: 4 months

Area under the curve (AUC0-inf)

Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)

Time frame: 4 months

Blood clearance (CL)

Pharmacokinetics parameter to determin clearance considering terminal elimination rate

Time frame: 4 months

Half life (t1/2)

Pharmacokinetics parameter to determin half-life rate (t1/2)

Time frame: 4 months

Volume of distribution (Vdss)

Data from ClinicalTrials.gov

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