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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070846
• Other study ID #: LG-GDCL005
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2020
• Est. completion date: March 7, 2020

Study information

• Verified date: June 2020
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 7, 2020
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• [14C] LC350189
Carbon-14 labelded LC350189

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Incidence of adverse events	Safety	form baseline up to Day 11