Clinical Study to Assess Safety, PK and PD Parameters of CDR132L
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ClinicalTrials.gov Identifier: NCT04045405 |
Recruitment Status :
Completed
First Posted : August 5, 2019
Last Update Posted : March 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Drug: CDR132L | Phase 1 |
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 (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | June 21, 2019 |
Actual Primary Completion Date : | January 31, 2020 |
Actual Study Completion Date : | June 26, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: CDR132L |
Drug: CDR132L
i.v. administration |
Placebo Comparator: Saline |
Drug: CDR132L
i.v. administration |
- Incidence of treatment-emergent adverse events [safety and tolerability] [ Time Frame: 4 months ]The incidence and severity of treatment-emergent adverse events (TEAEs)
- Maximum plasma concentration (Cmax) [ Time Frame: 4 months ]Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)
- 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)
- 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)
- 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)
- Blood clearance (CL) [ Time Frame: 4 months ]Pharmacokinetics parameter to determin clearance considering terminal elimination rate
- Half life (t1/2) [ Time Frame: 4 months ]Pharmacokinetics parameter to determin half-life rate (t1/2)
- Volume of distribution (Vdss) [ Time Frame: 4 months ]Pharmacokinetics parameter
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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),
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045405
United Kingdom | |
Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge | |
London, United Kingdom, SE1 1YR |
Study Director: | Wilfried Hauke, MD MFPM | Cardior Pharmaceuticals GmbH CMO | |
Principal Investigator: | Jorg Taubel, MD FFPM | Richmond Pharmacology Ltd CEO |
Responsible Party: | Cardior Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT04045405 |
Other Study ID Numbers: |
CDR132L-FIH01 2019-001291-10 ( EudraCT Number ) |
First Posted: | August 5, 2019 Key Record Dates |
Last Update Posted: | March 9, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Failure Heart Diseases Cardiovascular Diseases |