Clinical trial NCT04966325: Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
Official title: A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of LC350189 on the QTc (Corrected QT) Interval in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperuricemia
Gout
Qt Interval, Variation in
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-07-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4-way cross over
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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, would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern to the subject.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: The placebo-corrected change from baseline in HR (heart rate)
timeFrame: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
measure: The placebo-corrected change from baseline in PR
timeFrame: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
measure: The placebo-corrected change from baseline in QRS
timeFrame: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
References: