Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
Primary Purpose
Hyperuricemia, Gout, Qt Interval, Variation in
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
LC350189 200mg
Placebo
Moxifloxacin 400mg
LC350189 600mg
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia
Eligibility Criteria
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.
Sites / Locations
- PPD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
Treatment T (Therapeutic dose)
Treatment ST (Supratherapeutic dose)
Treatment P (Placebo)
Treatment M (positive control)
Arm Description
Single oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets.
Single oral dose of 600 mg LC350189 (3 × 200 mg tablets).
Single oral dose of 3 × placebo tablets.
Single oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label)
Outcomes
Primary Outcome Measures
The placebo-corrected change from baseline in QTcF
QTcF will be analyzed using concentration-QT (cQT) modeling
Secondary Outcome Measures
The placebo-corrected change from baseline in HR (heart rate)
HR will be evaluated at each postdose time point
The placebo-corrected change from baseline in PR
PR will be evaluated at each postdose time point
The placebo-corrected change from baseline in QRS
QRS will be evaluated at each postdose time point
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04966325
Brief Title
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Gout, Qt Interval, Variation in
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
4-way cross over
Masking
ParticipantInvestigator
Masking Description
LC350189 and placebo will be administered in a double blind, double-dummy manner. Moxifloxacin will be administered open-label.
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment T (Therapeutic dose)
Arm Type
Experimental
Arm Description
Single oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets.
Arm Title
Treatment ST (Supratherapeutic dose)
Arm Type
Experimental
Arm Description
Single oral dose of 600 mg LC350189 (3 × 200 mg tablets).
Arm Title
Treatment P (Placebo)
Arm Type
Placebo Comparator
Arm Description
Single oral dose of 3 × placebo tablets.
Arm Title
Treatment M (positive control)
Arm Type
Active Comparator
Arm Description
Single oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label)
Intervention Type
Drug
Intervention Name(s)
LC350189 200mg
Other Intervention Name(s)
LC350189 (therapeutic dose)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo control
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 400mg
Other Intervention Name(s)
Positive control
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
LC350189 600mg
Other Intervention Name(s)
LC350189 (supratherapeutic dose)
Intervention Description
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)
Primary Outcome Measure Information:
Title
The placebo-corrected change from baseline in QTcF
Description
QTcF will be analyzed using concentration-QT (cQT) modeling
Time Frame
Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
Secondary Outcome Measure Information:
Title
The placebo-corrected change from baseline in HR (heart rate)
Description
HR will be evaluated at each postdose time point
Time Frame
Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
Title
The placebo-corrected change from baseline in PR
Description
PR will be evaluated at each postdose time point
Time Frame
Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
Title
The placebo-corrected change from baseline in QRS
Description
QRS will be evaluated at each postdose time point
Time Frame
Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
PPD
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
To be determined
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Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
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