PPD
Austin, Texas, 78744, United States
NCT Number: NCT04966325
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.
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Notify Me18 year–55 year
All sexes
Interventional
Early Phase 1
Austin, Texas, 78744, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Other names: LC350189 (therapeutic dose)
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)
Other names: Placebo control
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)
Other names: Positive control
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)
Other names: LC350189 (supratherapeutic dose)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
LG Chem
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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