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

NCT03492996 | Completed Phase 1 FDA Drug

• 1 other identifier: LCB01-0371-17-1-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

  an average of 8 days (+ - 1 D)

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

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

Eligibility Criteria

• Age: 19 Years - 46 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LigaChem Biosciences, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• Howard Lee

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: April 10, 2018
• Study Start: June 21, 2020
• Primary Completion: August 3, 2020
• Study Completion: September 23, 2020
• Last Updated: March 12, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)