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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966325
Other study ID # LG-GDCL008
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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