BradycardiaPhase 1/2NCT05117346
An Exploratory Safety and Efficacy Clinical Study of CARDIX-101 for the Treatment of Chronic Bradycardia
A Phase 1/2 study testing CARDIX-101A, CARDIX-101B, CARDIX-101C in people with Bradycardia, run by Cardix Therapeutics LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bradycardia
- What is being tested?
- CARDIX-101A, CARDIX-101B, CARDIX-101C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 30 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- There is a history of ventricular tachycardia requiring drug or device therapy.
- Participation in another investigational drug or device trial within 30 days prior to the study. (subjects in registries may participate with the approval of the registry sponsor.)
- Acute cardiovascular events (myocardial infarction, pulmonary embolism, cerebrovascular accident, unstable angina, or transient ischemic attack) within 90 days prior to enrollment.
- Psychiatric disorder, active alcohol/drug abuse, or other circumstance or condition that, in the Investigator's opinion, may interfere with any aspect of protocol adherence or a subject's ability to give informed consent.
- Untreated hyperthyroidism or hypothyroidism.
- Acute pericarditis.
- Unrelated illness such as substantial infection, fever, or prescribed antibiotics in the last seven days, acute rheumatic fever, metastatic cancer, severe hepatic disease, or other extreme medical conditions
- Exclusion of a woman who is breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Following FDA and ICH Good Clinical Practice (GCP) guidance, a clinical Phase I study titled "A Single Ascending Dose Clinical Study to Establish Safety and Tolerability of CARDIX-101 in Bradycardia Patients" was conducted at the University of California San Diego (UCSD) School of Medicine, Cardiac Electrophysiology Center, and Altman Clinical and Translational Research Institute and was completed in August 2020 under IND# 131775.
The clinical Phase 1 study of CARDIX-101 was completed using eighteen patients with six ascending single-dose levels. There were no adverse effects observed or reported for all participating subjects related to the investigational medicine.
A current clinical Phase IIA study, "An Exploratory Safety and Efficacy Study of CARDIX-101 for the treatment of Chronic Bradycardia," is a multi-center clinical study. The current clinical study is designed to utilize appropriate wearable monitoring devices for today's Decentralized Clinical Trial.
This study will consist of a multi-site clinical exploratory study in chronic bradycardia patients. The study is open-label, and enrollment of a cohort occurs without randomization.
The study investigates three dosage levels of CARDIX-101 (CARDIX-101A, CARDIX-101B, and CARDIX-101C). The initial cohort will be enrolled in a staggered manner. In this way, it will make the clinical study more accessible for the patient to participate.
- Conditions
- Bradycardia
- Being tested
- CARDIX-101A, CARDIX-101B, CARDIX-101C
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDIX-101A, CARDIX-101B, CARDIX-101CDrug
Also called CARDIX-101
Each subject will receive, via oral administration, one capsule of study medicine per dose and three doses per day for 14±2-days treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CARDIX-101A, CARDIX-101B, CARDIX-101C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: The time frame is during medication 14±2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Dec 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study investigates three dosage levels of CARDIX-101 (CARDIX-101A, CARDIX-101B, and CARDIX-101C).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardix Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117346
- Sponsor's protocol ID
- CARDIX Therapeutics LLC
- Status last verified
- Aug 2024
- First submitted
- 24 Oct 2021
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan to make individual participant data available to other research.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Safety and Efficacy Clinical Study of CARDIX-101 for the Treatment of Chronic Bradycardia
- ClinicalTrials.gov ID
- NCT05117346
- Acronym / sponsor ID
- CARDIX Therapeutics LLC
- Conditions
- Bradycardia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardix Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following FDA and ICH Good Clinical Practice (GCP) guidance, a clinical Phase I study titled "A Single Ascending Dose Clinical Study to Establish Safety and Tolerability of CARDIX-101 in Bradycardia Patients" was conducted at the University of California San Diego (UCSD) School of Medicine, Cardiac Electrophysiology Center, and Altman Clinical and Translational Research Institute and was completed in August 2020 under IND# 131775.
The clinical Phase 1 study of CARDIX-101 was completed using eighteen patients with six ascending single-dose levels. There were no adverse effects observed or reported for all participating subjects related to the investigational medicine.
A current clinical Phase IIA study, "An Exploratory Safety and Efficacy Study of CARDIX-101 for the treatment of Chronic Bradycardia," is a multi-center clinical study. The current clinical study is designed to utilize appropriate wearable monitoring devices for today's Decentralized Clinical Trial.
This study will consist of a multi-site clinical exploratory study in chronic bradycardia patients. The study is open-label, and enrollment of a cohort occurs without randomization.
The study investigates three dosage levels of CARDIX-101 (CARDIX-101A, CARDIX-101B, and CARDIX-101C). The initial cohort will be enrolled in a staggered manner. In this way, it will make the clinical study more accessible for the patient to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study investigates three dosage levels of CARDIX-101 (CARDIX-101A, CARDIX-101B, and CARDIX-101C).
| Arm | Type | Receives |
|---|---|---|
| To Establish the Safety and Efficacy of CARDIX-101 in Chronic Bradycardia Patients | Experimental | Drug: CARDIX-101A, CARDIX-101B, CARDIX-101CTreatment 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARDIX-101A, CARDIX-101B, CARDIX-101CAlso: CARDIX-101Each subject will receive, via oral administration, one capsule of study medicine per dose and three doses per day for 14±2-days treatment. | Drug | To Establish the Safety and Efficacy of CARDIX-101 in Chronic Bradycardia Patients |
Primary outcome
The primary endpoint
Time frame: The time frame is during medication 14±2 days
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Undecided. There is no plan to make individual participant data available to other research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CARDIX-101A, CARDIX-101B, CARDIX-101C in people with Bradycardia, run by Cardix Therapeutics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint (time frame: The time frame is during medication 14±2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.