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

LG Chem

Status and phase: Completed; Early Phase 1

Conditions: Qt Interval, Variation in; Hyperuricemia; Gout

Treatments: Drug: Moxifloxacin 400mg; Drug: LC350189 200mg; Drug: LC350189 600mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04966325

LG-GDCL008

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 4 patient groups, including a placebo group

Treatment T (Therapeutic dose)

Experimental group

Description:

Single oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets.

Treatment:

Drug: LC350189 200mg

Treatment ST (Supratherapeutic dose)

Experimental group

Description:

Single oral dose of 600 mg LC350189 (3 × 200 mg tablets).

Treatment:

Drug: LC350189 600mg

Treatment P (Placebo)

Placebo Comparator group

Description:

Single oral dose of 3 × placebo tablets.

Treatment:

Drug: Placebo

Treatment M (positive control)

Active Comparator group

Description:

Single oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label)

Treatment:

Drug: Moxifloxacin 400mg