Heart Failure
Conditions
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.
Interventions
DRUGCDR132L
i.v. administration
Sponsors
Cardior Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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),
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events [safety and tolerability] | 4 months | The incidence and severity of treatment-emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Maximum plasma concentration (Cmax) | 4 months | Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax) |
| Half life (t1/2) | 4 months | Pharmacokinetics parameter to determin half-life rate (t1/2) |
| Volume of distribution (Vdss) | 4 months | Pharmacokinetics parameter |
| Blood clearance (CL) | 4 months | Pharmacokinetics parameter to determin clearance considering terminal elimination rate |
Countries
United Kingdom
Outcome results
None listed