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NCT Number: NCT04045405

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

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

London, SE1 1YR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

CDR132L

Drug

i.v. administration

Primary outcomes

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

    Time frame: 4 months

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

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 4 months

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

  2. Time to reach maximum plasma concentration (Tmax)

    Time frame: 4 months

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

  3. Area under the curve (AUC0-t)

    Time frame: 4 months

    Pharmacokinetics parameter area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t)

  4. Area under the curve (AUC0-inf)

    Time frame: 4 months

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

  5. Blood clearance (CL)

    Time frame: 4 months

    Pharmacokinetics parameter to determin clearance considering terminal elimination rate

  6. Half life (t1/2)

    Time frame: 4 months

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

  7. Volume of distribution (Vdss)

    Time frame: 4 months

    Pharmacokinetics parameter

Sponsors and collaborators

Lead sponsor

Cardior Pharmaceuticals GmbH

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2019
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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