Clinical trial NCT04066712: Renal PK Study of LC350189
Official title: A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LC350189 in Subjects With Varying Degrees of Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Hyperuricemia
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUC from time 0 to the last quantifiable concentration
timeFrame: Before dosing on Days 1 through Day 8
measure: AUC from time 0 to 24 hours post dose
timeFrame: Before dosing on Days 1 through Day 8
measure: AUC from time 0 to the end of the dosing interval at steady state
timeFrame: Before dosing on Days 1 through Day 8
measure: Maximum observed plasma concentration
timeFrame: Before dosing on Days 1 through Day 8
measure: Maximum observed plasma concentration at steady state
timeFrame: Before dosing on Days 1 through Day 8
measure: Time to reach maximum observed plasma concentration
timeFrame: Before dosing on Days 1 through Day 8
measure: Time to reach maximum observed plasma concentration at steady state
timeFrame: Before dosing on Days 1 through Day 8
measure: Amount of drug excreted in urine (Ae) over each collection interval
timeFrame: Before dosing on Days 1 through Day 8
Secondary outcomes:
measure: Serum mean concentration over 24 hours
timeFrame: Before dosing on Days 1 through Day 8
measure: Maximum observed effect
timeFrame: Before dosing on Days 1 through Day 8
measure: Time to reach maximum effect
timeFrame: Before dosing on Days 1 through Day 8
measure: Incidence of adverse events
timeFrame: Days 1 through Day 9 (end of study)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
References: