The primary objectives of the study are: • To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a \[14C\]-LCB01-0371-tracer dose to healthy subjects
This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for evaluation of the primary objectives. Study subjects will be screened for eligibility to participate in the study within 28 days before dosing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a \[14C\]-LCB01-0371-tracer dose to healthy subjects
Seoul National University Hospital
Seoul, South Korea
Assess the AME of LCB01-0371
To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a \[14C\]-LCB01-0371-tracer dose to healthy subjects. Blood, urine, feces, and expired air samples will be collected according to the following schedules 1. Blood: Plasma(20 points), Whole blood(2 points) 2. Urine : 11 points 3. Feces : 8 points 4. Expired air: 14points
Time frame: an average of 8 days (+ - 1 D)
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