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

• Sponsor: LG Chem (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04886050
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gout; Hyperuricemia	Drug: LC350189 Tablet; Drug: LC350189 Capsule	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 31, 2021
• Actual Primary Completion Date: Sep 16, 2021
• Actual Study Completion Date: Dec 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [From baseline up to Day 8 (72 hours post on Day 5)]

   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

Secondary Outcome Measures

1. Incidence of Adverse events [From baseline up to Day 8]

   Safety assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD	Las Vegas	Nevada	United States	89113

Sponsors and Collaborators

• LG Chem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LG Chem
• ClinicalTrials.gov Identifier: NCT04886050
• Other Study ID Numbers: LG-GDCL007
• First Posted: May 13, 2021
• Last Update Posted: Jan 6, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by LG Chem: bioavailability; relative
• Additional relevant MeSH terms: Hyperuricemia

Study Results

No Results Posted as of Jan 6, 2022