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

NCT ID: NCT04886050

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-12-10

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.

Conditions

Gout; Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LC350189 Formulation A (Tablet)

Each subject will be administered a single LC350189 200mg (QD) Tablet on Day 1 and Day 5, respectively.

Group Type: ACTIVE_COMPARATOR

LC350189 Tablet

Intervention Type: DRUG

Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5

LC350189 Formulation B (Capsule)

Each subject will be administered two LC350189 100mg (QD) Capsules (2 x 100-mg capsules) on Day 1 or Day 5, respectively.

Group Type: ACTIVE_COMPARATOR

LC350189 Capsule

Intervention Type: DRUG

Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5

Interventions

LC350189 Tablet

Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5

Intervention Type: DRUG

LC350189 Capsule

Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5

Intervention Type: DRUG

Other Intervention Names

LC350189; 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

LG-GDCL007

Identifier Type: -

Identifier Source: org_study_id