Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults

Study Overview
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Brief Summary
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This is an open-label, randomized, crossover, single dose study. Two single doses of LC350189(tablet or capsule formulations) will be administered with a washout period of at least 4-day between the doses to investigate the relative bioavailability of LC350189 after administration via tablet formulation compared with capsule formulation and to evaluate basic systemic pharmacokinetic parameters of the tablet formulation compared to the capsule formulation of LC350189.

Official Title
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A Phase 1, Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Bioavailability of an LC350189 Tablet Relative to an LC350189 Capsule in Healthy Subjects

Conditions
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Gout, Hyperuricemia

Intervention / Treatment
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* Drug: LC350189 Tablet
* Drug: LC350189 Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is male or female 18 to 50 years of age, inclusive. The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening. The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening. The subject agrees to comply with all protocol requirements. The subject is able to provide written informed consent. Exclusion Criteria: The subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator. The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening. The subject has a positive test result for SARS-CoV-2 at screening. The subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study. The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study. The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug. The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits). The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LC350189 Formulation A (Tablet)<br>Each subject will be administered a single LC350189 200mg (QD) Tablet on Day 1 and Day 5, respectively. | Drug: LC350189 Tablet<br>* Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5<br>* Other names: LC350189;|
| Active Comparator: LC350189 Formulation B (Capsule)<br>Each subject will be administered two LC350189 100mg (QD) Capsules (2 x 100-mg capsules) on Day 1 or Day 5, respectively. | Drug: LC350189 Capsule<br>* Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5<br>* Other names: LC350189;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative bioavailability of LC350189 after administration via tablet formulation compared with capsule formulation by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulation capsule formation | Blood sample for determination of plasma concentration of LC350189 will be collected at pre-dose and 0.5,1,2,4,6,8,16,24,36,48, and 72 hours | From baseline up to Day 8 (72 hours post on Day 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse events | Safety assessment | From baseline up to Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioavailability, relative