Hyperuricemia, Gout, Qt Interval, Variation in
Conditions
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.
Interventions
DRUGLC350189 200mg
Subject will receive an LC350189 200mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
DRUGPlacebo
Subject will receive a Placebo as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
Subject will receive a Moxifloxacin 400mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
DRUGLC350189 600mg
Subject will receive an LC350189 600mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
LC350189 and placebo will be administered in a double blind, double-dummy manner. Moxifloxacin will be administered open-label.
Intervention model description
4-way cross over
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The placebo-corrected change from baseline in QTcF | Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period | QTcF will be analyzed using concentration-QT (cQT) modeling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The placebo-corrected change from baseline in HR (heart rate) | Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period | HR will be evaluated at each postdose time point |
| The placebo-corrected change from baseline in PR | Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period | PR will be evaluated at each postdose time point |
| The placebo-corrected change from baseline in QRS | Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period | QRS will be evaluated at each postdose time point |
Countries
United States
Outcome results
None listed