Mass Balance Study of [14C]LC350189 in Healthy Volunteers

A Phase 1, Open-Label, Single-Dose, Mass Balance Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-LC350189 in Healthy Male Subjects

This is a Phase 1, open-label, single-dose, mass balance study designed to evaluate the absorption, metabolism, and excretion of [14C] radiolabeled LC350189 after oral administration.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout
• Intervention / Treatment: Drug: [14C] LC350189

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• The subject is male 18 to 55 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 results, and physical examination findings at screening.
• The subject is able to provide written informed consent.

Exclusion Criteria:

• The subject has a medical history of any issues affecting absorption or metabolism, as judged by the investigator.
• The subject has a medical history of any problems affecting venous access or bowel/bladder function.
• 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 used any prescription 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.
• 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 during the study.
• 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.
• The subject is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or during the study.
• The subject has donated blood or blood products >450 mL within 30 days before the first dose of study drug.
• The subject has a history of relevant drug and/or food allergies (ie, allergy to study drug or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [14C] LC350189; Single oral dose	Drug: [14C] LC350189; Carbon-14 labelded LC350189

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass balance recovery of total radioactivity in whole blood and plasma.	Radioactivity is measured by radiation dosimetry.	Before dosing on Days 1 through Day 10 (240 hours)
Mass balance recovery of total radioactivity in whole urine, and feces.	Radioactivity is measured by radiation dosimetry.	Before dosing on Days 1 through Day 10 (240 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Safety	form baseline up to Day 11

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2020
• Primary Completion (ACTUAL): March 7, 2020
• Study Completion (ACTUAL): March 7, 2020

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 25, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: LG-GDCL005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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