Back to resultsMass Balance Study of [14C]LC350189 in Healthy Volunteers
Primary Purpose
Gout, Hyperuricemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[14C] LC350189
Sponsored by
About this trial
This is an interventional treatment trial for Gout
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).
Sites / Locations
- PPD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[14C] LC350189
Arm Description
Single oral dose
Outcomes
Primary Outcome Measures
Mass balance recovery of total radioactivity in whole blood and plasma.
Radioactivity is measured by radiation dosimetry.
Mass balance recovery of total radioactivity in whole urine, and feces.
Radioactivity is measured by radiation dosimetry.
Secondary Outcome Measures
Incidence of adverse events
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04070846
Brief Title
Mass Balance Study of [14C]LC350189 in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
March 7, 2020 (Actual)
Study Completion Date
March 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[14C] LC350189
Arm Type
Experimental
Arm Description
Single oral dose
Intervention Type
Drug
Intervention Name(s)
[14C] LC350189
Intervention Description
Carbon-14 labelded LC350189
Primary Outcome Measure Information:
Title
Mass balance recovery of total radioactivity in whole blood and plasma.
Description
Radioactivity is measured by radiation dosimetry.
Time Frame
Before dosing on Days 1 through Day 10 (240 hours)
Title
Mass balance recovery of total radioactivity in whole urine, and feces.
Description
Radioactivity is measured by radiation dosimetry.
Time Frame
Before dosing on Days 1 through Day 10 (240 hours)
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Safety
Time Frame
form baseline up to Day 11
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
PPD
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mass Balance Study of [14C]LC350189 in Healthy Volunteers
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