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OpenTrials
Completed

NCT Number: NCT04966325

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: LC350189 (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)

Other names: Placebo control

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)

Other names: 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)

Other names: LC350189 (supratherapeutic dose)

Primary outcomes

  1. The placebo-corrected change from baseline in QTcF

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

    QTcF will be analyzed using concentration-QT (cQT) modeling

Secondary outcomes

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

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

    HR will be evaluated at each postdose time point

  2. The placebo-corrected change from baseline in PR

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

    PR will be evaluated at each postdose time point

  3. The placebo-corrected change from baseline in QRS

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

    QRS will be evaluated at each postdose time point

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2021
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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