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

NCT04886050 | Completed Phase 1 FDA Drug

• 1 other identifier: LG-GDCL007
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

bioavailability; relative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Adverse events

  From baseline up to Day 8

Study Arms (2)

LC350189 Formulation A (Tablet)

ACTIVE COMPARATOR

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

Drug: LC350189 Tablet

LC350189 Formulation B (Capsule)

ACTIVE COMPARATOR

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

Interventions

LC350189 Tablet DRUG

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

Also known as: LC350189

LC350189 Formulation A (Tablet)

LC350189 Capsule DRUG

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

Also known as: LC350189

LC350189 Formulation B (Capsule)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

PPD

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: July 31, 2021
• Primary Completion: September 16, 2021
• Study Completion: December 10, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-12

Locations

US (1)