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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose

• Registration Number: NCT03492996
• Lead Sponsor: LigaChem Biosciences, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-04-01
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-10
• Study Start: 2020-06-21
• Primary Completion: 2020-08-03
• Study Completion: 2020-09-23
• Status Verified: 2020-11
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1. Healthy male adults aged 19 to 45 (inclusive) years
2. Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2
3. Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form
4. Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
5. Subject who were not to have a history of drug hypersensitivity or allergic reactions related to antibiotics, etc

Exclusion Criteria

1. Subjects who had a clinically significant disease or a past history of disease
2. 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.
3. 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
4. Subjects who had history of drug abuse or showed a positive result on a drug screening urine test.
5. Subjects who showed a positive result for a serology test (HBsAg, Anti-HCV , HIV Ab, or VDRL), etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCB01-0371 dose with a [14C]-LCB01-0371-tracer	LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose	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

Primary Outcome Measures

Name	Time	Method
Assess the AME of LCB01-0371	an average of 8 days (+ - 1 D)	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of