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

NCT04070846 | Completed Phase 1 FDA Drug

• 1 other identifier: LG-GDCL005
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of adverse events

  form baseline up to Day 11

Study Arms (1)

[14C] LC350189

EXPERIMENTAL

Single oral dose

Drug: [14C] LC350189

Interventions

[14C] LC350189 DRUG

Carbon-14 labelded LC350189

[14C] LC350189

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: February 26, 2020
• Primary Completion: March 7, 2020
• Study Completion: March 7, 2020
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

US (1)