Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Hyperuricemia, Gout, Qt Interval, Variation in

In brief

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.

Key facts

Study ID

NCT04966325

Run by

LG Chem

People needed

37

Starts

2021-09-23

Expected to finish

2021-12-07

Last updated by the study team

2022-01-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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