An Exploratory Safety and Efficacy Clinical Study of CARDIX-101 for the Treatment of Chronic Bradycardia

NCT05117346 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CARDIX Therapeutics LLC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of chronic bradycardia, one of the cardiovascular diseases, remains an essential unsolved issue. The objective of this project is to speed up a new drug CARDIX-101 clinical Phase 1IA trial for the treatment of chronic bradycardia and to solve an unmet medical need. To date, there is no regulatory approved drug of this type available in the U.S or the world. If the new drug CARDIX-101 demonstrated a significant positive effect on chronic bradycardia, it should have a sizeable demand and solve an unmet medical need.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

• The primary endpoint

  The primary endpoint measures the mean Heart Rate. During the treatment period of 14±2-day, each patient is required to use near-real-time HR/ECG monitoring for a total of 14±2-day with no less than 16±6-hours of monitoring per day. The increase in the clinical study period (14±2 days) for a patient compared to patient heart rate before dosing of CARDIX-101 (either by baseline record for 2-hours or historical patient records for mean Heart Rate of 5-days). The measure results are as follows: Effectiveness/Significance Level 1: H.R. increase 5-10% Effectiveness/Significance Level 2: H.R. increase 10-15% Effectiveness/Significance Level 3: H.R. increase 15-20% Effectiveness/Significance Level 4: H.R. increase ≥20%

  The time frame is during medication 14±2 days

Study Arms (1)

To Establish the Safety and Efficacy of CARDIX-101 in Chronic Bradycardia Patients

EXPERIMENTAL

Treatment Regimen: A total of 20±4 chronic bradycardia subjects with a heart rate (H.R.) average of less than 60 bpm will be enrolled in the study (6±3/cohort). A clinical study period of 14±2-days is planned for each enrollment of patients. Route of Administration: Each subject will receive, via oral administration, one capsule of study medicine per dose and three doses per day for 14±2-days treatment.

Drug: CARDIX-101A, CARDIX-101B, CARDIX-101C

Interventions

CARDIX-101A, CARDIX-101B, CARDIX-101C DRUG

Each subject will receive, via oral administration, one capsule of study medicine per dose and three doses per day for 14±2-days treatment.

Also known as: CARDIX-101

To Establish the Safety and Efficacy of CARDIX-101 in Chronic Bradycardia Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has bradycardia (H.R. \<60 BPM). The subject's symptoms, if any, such as dizziness, confusion, fatigue, shortness of breath, chest pain, and syncope, are required to be documented in the case report form (CRF) in the screening, treatment, and follow-up periods.
• The subject has been informed of the investigational nature of this study and has completed a written informed consent form (ICF) in accordance with institutional, local, and national guidelines.
• The subject is able to return for the safety and efficacy follow up period and provides at least two modes of contact information (e.g., home and mobile phone numbers, address) and contact information for at least one close contact (e.g., family member or friend) to facilitate follow up.
• The subject is a male or female 18-80 years of age.

You may not qualify if:

• Patients with peptic ulcer disease, seizure disorder, or cardiac arrhythmia with tachycardia are excluded
• Patients with asthma who are already taking a beta-agonist and/or Theophylline are excluded
• Pregnancy (all women of childbearing potential, unless surgically sterilized or post-menopausal defined as the cessation of menses for over one year, receive a pregnancy test).
• Systolic blood pressure is \<100 mmHg.
• Heart rate \>60 bpm.
• Severe bradycardia or sinus pauses, which in the opinion of the P.I. requires urgent pacemaker implantation or A.V. block \> 2nd degree, or existing implanted pacemaker.
• Serum potassium \<4.0 mEq/L or mmol/L by the local laboratory at the screening.
• History of receiving another Class I or Class III antiarrhythmic drug within three days prior to enrollment. Excluded Class I antiarrhythmic drugs include quinidine, procainamide, disopyramide, lignocaine, mexiletine, flecainide, and propafenone. Excluded Class III drugs include dofetilide, sotalol, dronedarone, and ranolazine.
• There is a history of amiodarone (oral or IV) within 90 days prior to the study.
• There is native or prosthetic aortic or mitral stenosis with aortic valve area ≤1.0 cm2, or mitral valve area of \<1.5 cm2 or any other valvular diseases requiring surgery.
• There is an ejection fraction of \<35% within one year prior to enrollment (most recent measure if more than one).
• Atrial fibrillation (A.F.) or atrial flutter (AFL) as a result of surgery (postoperative AF/AFL) within 30 days prior to the study.
• There is a history of electrical cardioversion within seven calendar days prior to the study.
• There is a history of any polymorphic ventricular tachycardia, including torsade de points.
• History or family history of long Q.T. syndrome or other inherited arrhythmia syndrome.

Sponsors & Collaborators

• Cardix Therapeutics LLC: lead

Study Sites (1)

SpaceMed-X

San Diego, California, 92126, United States

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study investigates three dosage levels of CARDIX-101 (CARDIX-101A, CARDIX-101B, and CARDIX-101C).

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 11, 2021
• Study Start: December 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

US (1)