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

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

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 Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout; Qt Interval, Variation in
• Intervention / Treatment: Drug: LC350189 200mg; Drug: LC350189 600mg; Drug: Placebo; Drug: Moxifloxacin 400mg

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment T (Therapeutic dose); Single oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets.	Drug: 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); Other Names: LC350189 (therapeutic dose)
Experimental: Treatment ST (Supratherapeutic dose); Single oral dose of 600 mg LC350189 (3 × 200 mg tablets).	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); Other Names: LC350189 (supratherapeutic dose)
Placebo Comparator: Treatment P (Placebo); Single oral dose of 3 × placebo tablets.	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); Other Names: Placebo control
Active Comparator: Treatment M (positive control); Single oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label)	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); Other Names: Positive control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The placebo-corrected change from baseline in QTcF	QTcF will be analyzed using concentration-QT (cQT) modeling	Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The placebo-corrected change from baseline in HR (heart rate)	HR will be evaluated at each postdose time point	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	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	Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: LG-GDCL008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No