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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966325
• Other study ID #: LG-GDCL008
• Status: Completed
• Phase: Early Phase 1
• Start date: September 23, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: December 2021
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Hyperuricemia
• Qt Interval, Variation in

Intervention

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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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