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Potassium Channel Modulator
LQT-1213 for Long QT Syndrome
Phase 1 & 2
Recruiting
Led By Jan Matousek, DO
Research Sponsored by Thryv Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 2.5, 3, 3.5, and 4 hours after administration of study treatment.
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a new drug to reduce heart risks in healthy adults and those with a heart condition. Up to 28 healthy adults & 12 with heart condition tested.
Who is the study for?
Healthy adults and patients with Type 2 or 3 Long QT Syndrome (LQT2 or LQT3) can join this trial. Healthy participants must be 19-60 years old, have a BMI of 18-35 kg/m^2, not have used tobacco recently, and agree to use effective contraception. Patients with LQT need an ICD implanted and a specific QTcF interval. People with certain health conditions, recent blood donations, drug abuse history, or those on conflicting medications cannot participate.Check my eligibility
What is being tested?
The study tests the effects of LQT-1213 on heart rhythm prolongation caused by Dofetilide in healthy subjects (Part1), followed by its safety in patients with congenital Long QT syndrome types LQT2 or LQT3 (Part2). Part1 is a crossover study where subjects receive both treatments at different times; Part2 involves multiple doses for safety evaluation.See study design
What are the potential side effects?
Potential side effects are not detailed but would typically include reactions related to heart rhythm changes due to the nature of the drugs being tested which affect cardiac electrical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2, 2.5, 3, 3.5, and 4 hours after administration of study treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 2.5, 3, 3.5, and 4 hours after administration of study treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Pharmacodynamics: by-time point analysis for QTc on LQT-1213 versus placebo
Part 2: Safety and tolerability of oral LQT-1213 in participants with LQT-2 or LQT-3
Secondary outcome measures
Part 1: Pharmacokinetic Dofetilide AUC0-t
Part 1: Pharmacokinetic Dofetilide AUCtau
Part 1: Pharmacokinetic Dofetilide Cmax
+13 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: TID dosing of PlaceboExperimental Treatment1 Intervention
Placebo matched to LQT-1213 (Day 1)TID
Group II: Part 2: TID dosing of LQT-1213Experimental Treatment1 Intervention
LQT-1213 2.24 mg/kg/day TID (at time 0, 8 and 16 hours) on Days 2-4, with a final single morning dose on Day 4 at time 0, though these time points may be adjusted based upon emerging data.
Group III: Part 1: Arm A: 500 μg of Dofetilide BID in combination with dose-escalating LQT-1213 TID, orallyExperimental Treatment2 Interventions
Dofetilide 500 μg BID (2 × 250 μg capsules), orally (Days 1-8) and LQT-1213 3 times a day (TID) low dose (Days 3 and 4), mid dose (Days 5 and 6), and high dose (not to exceed 0.747 mg/kg TID, daily dose 2.24 mg/kg/day) on Days 7 and 8. The specific doses will be determined before administration of the first dose of LQT-1213, but the high dose will not exceed 0.747 mg/kg TID or 2.24 mg/kg/day. Only 1 dose of dofetilide and LQT-1213 will be administered on Day 8.
Group IV: Part 1: Arm B: 500 μg of Dofetilide BID in combination with placeboPlacebo Group2 Interventions
Dofetilide 500 μg BID (2 × 250 μg capsules), orally (Days 1-8) and placebo matched to LQT-1213 TID (Days 3-8). Only 1 dose of dofetilide and placebo matched to LQT-1213 will be administered on Day 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LQT-1213
2022
Completed Phase 1
~50
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Thryv Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Long QT Syndrome
50 Patients Enrolled for Long QT Syndrome
Jan Matousek, DOPrincipal InvestigatorSpaulding Clinical Research LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study's requirements and agree to participate.I am a woman who cannot have children because I am either surgically sterile or postmenopausal.My liver tests are not normal.I have no major health issues found in my physical exams or medical history.I have had a condition where my lymphocytes multiply unusually.I have a history of cancer.I am between 19 and 60 years old.I cannot stop taking certain drugs, herbal remedies, or supplements.I am not taking any medications that affect liver or kidney function.I am generally healthy.I have been sick within the last 14 days.I do not have any major health issues affecting my organs or mental health.I am using or willing to use effective birth control methods.I have no history of serious heart conditions or related family history.I am scheduled for surgery during the study period.I am not pregnant, breastfeeding, or planning to become pregnant.I am not planning to get any vaccinations.I haven't had cancer in the last 5 years, except for skin cancer.My kidney function is not normal.I am using reliable birth control methods.I am not taking medication that strongly activates liver enzymes.Your heart's QTcF interval is outside the range of 480 to 560 milliseconds.I am between 19 and 60 years old.My genetic test shows a harmful KCNH2 mutation, approved by the study sponsor.My weight is at least 45 kg and my BMI is between 18.0 and 35.0.Your body mass index (BMI) is between 18 and 32.My genetic test shows I have a specific mutation in the SCN5A gene that is considered harmful.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: TID dosing of Placebo
- Group 2: Part 1: Arm A: 500 μg of Dofetilide BID in combination with dose-escalating LQT-1213 TID, orally
- Group 3: Part 2: TID dosing of LQT-1213
- Group 4: Part 1: Arm B: 500 μg of Dofetilide BID in combination with placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians being enrolled in this clinical research endeavor?
"The minimum age requirement for these trials is 19 years old, with the upper limit of enrollment being 60."
Answered by AI
What are the qualifications for participating in this clinical research?
"This experiment is open to those with long qt syndrome, aged 19-60. A total of 28 individuals are sought for the trial."
Answered by AI
Is recruitment for this clinical experiment still open?
"This clinical trial, initially posted on March 8th 2023 and last updated on June 15th 2023, is not recruiting participants. However, there are currently 1,443 other relevant studies that patients may be interested in pursuing at this time."
Answered by AI
Who else is applying?
What site did they apply to?
Spaulding Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
In order to help others.
PatientReceived 1 prior treatment
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