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

LigaChem Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03492996

LCB01-0371-17-1-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 46 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

LCB01-0371 dose with a [14C]-LCB01-0371-tracer

Experimental group

Description:

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

Treatment:

Drug: LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose