HyperuricemiaEarly Phase 1NCT04966325
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
A Early Phase 1 study testing LC350189 200mg, Moxifloxacin 400mg and LC350189 600mg in people with Hyperuricemia and Gout, run by LG Chem at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Gout, Qt Interval, Variation in
- What is being tested?
- LC350189 200mg, Moxifloxacin 400mg and LC350189 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2021to 7 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- LC350189 200mg, Placebo, Moxifloxacin 400mg, LC350189 600mg
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC350189 200mgDrug
Also called LC350189 (therapeutic dose)
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)
PlaceboDrug
Also called Placebo control
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 400mgDrug
Also called Positive control
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 600mgDrug
Also called LC350189 (supratherapeutic dose)
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)
| Study group | Role | What they receive |
|---|---|---|
| Treatment T (Therapeutic dose) | Experimental | Single oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets. Receives: Drug: LC350189 200mg |
| Treatment ST (Supratherapeutic dose) | Experimental | Single oral dose of 600 mg LC350189 (3 × 200 mg tablets). Receives: Drug: LC350189 600mg |
| Treatment P (Placebo) | Placebo comparator | Single oral dose of 3 × placebo tablets. Receives: Drug: Placebo |
| Treatment M (positive control) | Active comparator | Single oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label) Receives: Drug: Moxifloxacin 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The placebo-corrected change from baseline in QTcF
QTcF will be analyzed using concentration-QT (cQT) modeling
Measured: 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)
HR will be evaluated at each postdose time point
Measured: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
The placebo-corrected change from baseline in PR
PR will be evaluated at each postdose time point
Measured: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
The placebo-corrected change from baseline in QRS
QRS will be evaluated at each postdose time point
Measured: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start23 Sep 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4-way cross over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966325
- Sponsor's protocol ID
- LG-GDCL008
- Status last verified
- Dec 2021
- First submitted
- 28 Jun 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04966325
- Acronym / sponsor ID
- LG-GDCL008
- Conditions
- Hyperuricemia, Gout, Qt Interval, Variation in
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 4-way cross over
| Arm | Type | Receives |
|---|---|---|
| Treatment T (Therapeutic dose) | Experimental | Drug: LC350189 200mgSingle oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets. |
| Treatment ST (Supratherapeutic dose) | Experimental | Drug: LC350189 600mgSingle oral dose of 600 mg LC350189 (3 × 200 mg tablets). |
| Treatment P (Placebo) | Placebo comparator | Drug: PlaceboSingle oral dose of 3 × placebo tablets. |
| Treatment M (positive control) | Active comparator | Drug: Moxifloxacin 400mgSingle oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC350189 200mgAlso: LC350189 (therapeutic dose)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) | Drug | Treatment T (Therapeutic dose) |
| PlaceboAlso: Placebo controlSubject 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) | Drug | Treatment P (Placebo) |
| Moxifloxacin 400mgAlso: Positive controlSubject 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) | Drug | Treatment M (positive control) |
| LC350189 600mgAlso: LC350189 (supratherapeutic dose)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) | Drug | Treatment ST (Supratherapeutic dose) |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: Undecided. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LC350189 200mg, Moxifloxacin 400mg and LC350189 600mg in people with Hyperuricemia and Gout, run by LG Chem at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.