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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
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)
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)
PPD
Austin, Texas, United States
The placebo-corrected change from baseline in QTcF
QTcF will be analyzed using concentration-QT (cQT) modeling
Time frame: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
The placebo-corrected change from baseline in HR (heart rate)
HR will be evaluated at each postdose time point
Time frame: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
The placebo-corrected change from baseline in PR
PR will be evaluated at each postdose time point
Time frame: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
The placebo-corrected change from baseline in QRS
QRS will be evaluated at each postdose time point
Time frame: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)