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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout
• Intervention / Treatment: Drug: LC350189 Tablet; Drug: LC350189 Capsule

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: LC350189 Formulation A (Tablet); Each subject will be administered a single LC350189 200mg (QD) Tablet on Day 1 and Day 5, respectively.	Drug: LC350189 Tablet; Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5; Other Names: LC350189
ACTIVE_COMPARATOR: 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.	Drug: LC350189 Capsule; Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5; Other Names: LC350189

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2021
• Primary Completion (ACTUAL): September 16, 2021
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 9, 2021
• First Posted (ACTUAL): May 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: bioavailability; relative
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: LG-GDCL007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No