Clinical trial NCT04886050: Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Hyperuricemia
Keywords: bioavailability
relative
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From baseline up to Day 8 (72 hours post on Day 5)
Secondary outcomes:
measure: Incidence of Adverse events
timeFrame: From baseline up to Day 8
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: PPD
state: Nevada
Study officials:
References: