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

NCT ID: NCT04966325

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-23
• Study Completion Date: 2021-12-07

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.

Conditions

Hyperuricemia; Gout; Qt Interval, Variation in

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment T (Therapeutic dose)

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

Group Type: EXPERIMENTAL

LC350189 200mg

Intervention Type: DRUG

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)

Treatment ST (Supratherapeutic dose)

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

Group Type: EXPERIMENTAL

LC350189 600mg

Intervention Type: DRUG

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)

Treatment P (Placebo)

Single oral dose of 3 × placebo tablets.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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)

Treatment M (positive control)

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

Group Type: ACTIVE_COMPARATOR

Moxifloxacin 400mg

Intervention Type: DRUG

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)

Interventions

LC350189 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)

Intervention Type: DRUG

Placebo

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)

Intervention Type: DRUG

Moxifloxacin 400mg

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)

Intervention Type: DRUG

LC350189 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)

Intervention Type: DRUG

Other Intervention Names

LC350189 (therapeutic dose); Placebo control; Positive control; LC350189 (supratherapeutic dose)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD

Austin, Texas, United States

Countries

United States

Other Identifiers

LG-GDCL008

Identifier Type: -

Identifier Source: org_study_id