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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment T (Therapeutic dose) | Experimental | Single oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets. |
|
| Treatment ST (Supratherapeutic dose) | Experimental | Single oral dose of 600 mg LC350189 (3 × 200 mg tablets). |
|
| Treatment P (Placebo) | Placebo Comparator | Single oral dose of 3 × placebo tablets. |
|
| Treatment M (positive control) | Active Comparator | Single oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The placebo-corrected change from baseline in PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States |
To be determined
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4-way cross over
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LC350189 and placebo will be administered in a double blind, double-dummy manner. Moxifloxacin will be administered open-label.
|
| 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) |
|
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| 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) |
|
|
| 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) |
|
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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 |
| 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 |
| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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