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

NCT ID: NCT04070846

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2020-03-07

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C] LC350189

Single oral dose

Group Type: EXPERIMENTAL

[14C] LC350189

Intervention Type: DRUG

Carbon-14 labelded LC350189

Interventions

[14C] LC350189

Carbon-14 labelded LC350189

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD

Austin, Texas, United States

Countries

United States

Other Identifiers

LG-GDCL005

Identifier Type: -

Identifier Source: org_study_id