Clinical trial NCT04070846: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Hyperuricemia
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Mass balance recovery of total radioactivity in whole blood and plasma.
timeFrame: Before dosing on Days 1 through Day 10 (240 hours)
measure: Mass balance recovery of total radioactivity in whole urine, and feces.
timeFrame: Before dosing on Days 1 through Day 10 (240 hours)
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: form baseline up to Day 11
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
References: