A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Mass Balance Study to Investigate the Absorption, Metabolism, Excretion of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371- Microtracer Dose in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male adults aged 19 to 45 (inclusive) years Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2 Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview. Subject who were not to have a history of drug hypersensitivity or allergic reactions related to antibiotics, etc Exclusion Criteria: Subjects who had a clinically significant disease or a past history of disease Subjects who had a past history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may have affected to absorption for the study drug. Subjects who had the following laboratory test results at screening; AST, ALT, and total bilirubin ≥ 1.5 times upper limit of normal or CK (Creatine Kinase) > 2.5 times upper limit of normal Subjects who had history of drug abuse or showed a positive result on a drug screening urine test. Subjects who showed a positive result for a serology test (HBsAg, Anti-HCV , HIV Ab, or VDRL), etc.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCB01-0371 dose with a [14C]-LCB01-0371-tracer<br>A mass balance study to investigate the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose in healthy male subjects | Drug: LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Blood: Plasma(20 points), Whole blood(2 points) Urine : 11 points Feces : 8 points Expired air: 14points | an average of 8 days (+ - 1 D) |