Renal PK Study of LC350189

NCT ID: NCT04066712

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2020-09-12

Brief Summary

This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.

Conditions

Gout; Hyperuricemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Normal (control) renal function

Group Type: EXPERIMENTAL

LC350189 200 mg

Intervention Type: DRUG

Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

B: Mild impairment renal function

Group Type: EXPERIMENTAL

LC350189 200 mg

Intervention Type: DRUG

Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

C: Moderate impairment renal function

Group Type: EXPERIMENTAL

LC350189 200 mg

Intervention Type: DRUG

Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

D: Severe impairment renal function

Group Type: EXPERIMENTAL

LC350189 200 mg

Intervention Type: DRUG

Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

Interventions

LC350189 200 mg

Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subject has a BMI of 18 to 40 kg/m2, inclusive, at screening.
• The subject is able to provide written informed consent.

For healthy subjects only : The subject has normal renal function as determined by eGFR and calculated using the MDRD formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.

For subjects with renal impairment only

: The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.

Exclusion Criteria

• The subject has a history or clinical manifestations of a significant neurological, cardiovascular, endocrine, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
• The subject has nephrotic syndrome, defined as serum albumin <3.0 g/dL and urine protein/creatinine ratio >350 mg/mmol (as an estimate of approximate proteinuria of >3.5 g/day) at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Other Identifiers

LG-GDCL003

Identifier Type: -

Identifier Source: org_study_id