Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy M… (NCT04966325) | Clinical Trial Compass
CompletedEarly Phase 1
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
United States37 participantsStarted 2021-09-23
Plain-language summary
This is a Phase 1, single-center, randomized, partially double-blind, placebo- and positive controlled, 4-way crossover study to evaluate the effect of a therapeutic and a supratherapeutic dose of LC350189 on the QTcF in healthy male and female subjects.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject is 18 to 55 years of age, inclusive, with a body mass index (BMI) 18 to 33 kg/m2, inclusive, at screening.
* The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
* The subject is able to provide written informed consent and agrees to comply with all protocol requirements.
Exclusion Criteria:
* The subject has a history of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, or angina.
* The subject has a family history of long QT syndrome, Brugada syndrome, or sudden death.
* The subject has a resting HR of \<40 bpm or \>100 bpm when vital signs are measured at screening or check-in.
* The subject has history or presence of unstable cardiovascular disease, including myocardial infarction, cardiac arrhythmia, or cerebrovascular disease (eg, cerebrovascular accident/stroke or transient ischemic attack).
* The subject has a history of other acute or chronic cardiovascular disease or coronary revascularization surgery (eg, coronary artery bypass graft, percutaneous transluminal coronary angioplasty).
* The subject uses a cardiac pacemaker.
* The subject has a history of any other medical, psychological, or social condition that, in the opinion of the investigator or the medical monitor,…
What they're measuring
1
The placebo-corrected change from baseline in QTcF
Timeframe: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period