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)
Overview
- Phase
- Phase 1
- Intervention
- CDR132L
- Conditions
- Heart Failure
- Sponsor
- Cardior Pharmaceuticals GmbH
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-emergent adverse events [safety and tolerability]
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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),
Arms & Interventions
CDR132L
Intervention: CDR132L
Saline
Intervention: CDR132L
Outcomes
Primary Outcomes
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
- Maximum plasma concentration (Cmax)(4 months)
- Time to reach maximum plasma concentration (Tmax)(4 months)
- Area under the curve (AUC0-t)(4 months)
- Area under the curve (AUC0-inf)(4 months)
- Blood clearance (CL)(4 months)
- Half life (t1/2)(4 months)
- Volume of distribution (Vdss)(4 months)