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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
CDR132L
Sponsored by
Cardior Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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),

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CDR132L

Saline

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events [safety and tolerability]
The incidence and severity of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Maximum plasma concentration (Cmax)
Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)
Time to reach maximum plasma concentration (Tmax)
Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)
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)
Area under the curve (AUC0-inf)
Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Blood clearance (CL)
Pharmacokinetics parameter to determin clearance considering terminal elimination rate
Half life (t1/2)
Pharmacokinetics parameter to determin half-life rate (t1/2)
Volume of distribution (Vdss)
Pharmacokinetics parameter

Full Information

First Posted
July 23, 2019
Last Updated
March 8, 2022
Sponsor
Cardior Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04045405
Brief Title
Clinical Study to Assess Safety, PK and PD Parameters of CDR132L
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardior Pharmaceuticals GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDR132L
Arm Type
Experimental
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CDR132L
Intervention Description
i.v. administration
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events [safety and tolerability]
Description
The incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)
Time Frame
4 months
Title
Time to reach maximum plasma concentration (Tmax)
Description
Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)
Time Frame
4 months
Title
Area under the curve (AUC0-t)
Description
Pharmacokinetics parameter area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t)
Time Frame
4 months
Title
Area under the curve (AUC0-inf)
Description
Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Time Frame
4 months
Title
Blood clearance (CL)
Description
Pharmacokinetics parameter to determin clearance considering terminal elimination rate
Time Frame
4 months
Title
Half life (t1/2)
Description
Pharmacokinetics parameter to determin half-life rate (t1/2)
Time Frame
4 months
Title
Volume of distribution (Vdss)
Description
Pharmacokinetics parameter
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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),
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried Hauke, MD MFPM
Organizational Affiliation
Cardior Pharmaceuticals GmbH CMO
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorg Taubel, MD FFPM
Organizational Affiliation
Richmond Pharmacology Ltd CEO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33245749
Citation
Taubel J, Hauke W, Rump S, Viereck J, Batkai S, Poetzsch J, Rode L, Weigt H, Genschel C, Lorch U, Theek C, Levin AA, Bauersachs J, Solomon SD, Thum T. Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study. Eur Heart J. 2021 Jan 7;42(2):178-188. doi: 10.1093/eurheartj/ehaa898.
Results Reference
derived
PubMed Identifier
32105576
Citation
Huang CK, Kafert-Kasting S, Thum T. Preclinical and Clinical Development of Noncoding RNA Therapeutics for Cardiovascular Disease. Circ Res. 2020 Feb 28;126(5):663-678. doi: 10.1161/CIRCRESAHA.119.315856. Epub 2020 Feb 27.
Results Reference
derived

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

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