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

NCT04966325 | Completed Early Phase 1 FDA Drug

• 1 other identifier: LG-GDCL008
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The placebo-corrected change from baseline in HR (heart rate)

  Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period

• The placebo-corrected change from baseline in PR

  Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period

• The placebo-corrected change from baseline in QRS

  Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period

Study Arms (4)

Treatment T (Therapeutic dose)

EXPERIMENTAL

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

Drug: LC350189 200mg

Treatment ST (Supratherapeutic dose)

EXPERIMENTAL

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

Drug: LC350189 600mg

Treatment P (Placebo)

PLACEBO COMPARATOR

Single oral dose of 3 × placebo tablets.

Drug: Placebo

Treatment M (positive control)

ACTIVE COMPARATOR

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

Drug: Moxifloxacin 400mg

Interventions

LC350189 200mg 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)

Also known as: LC350189 (therapeutic dose)

Treatment T (Therapeutic dose)

Placebo 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)

Also known as: Placebo control

Treatment P (Placebo)

Moxifloxacin 400mg 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)

Also known as: Positive control

Treatment M (positive control)

LC350189 600mg 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)

Also known as: LC350189 (supratherapeutic dose)

Treatment ST (Supratherapeutic dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: LC350189 and placebo will be administered in a double blind, double-dummy manner. Moxifloxacin will be administered open-label.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4-way cross over

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 19, 2021
• Study Start: September 23, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-12

Locations

US (1)