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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492996
• Other study ID #: LCB01-0371-17-1-06
• Status: Completed
• Phase: Phase 1
• Start date: June 21, 2020
• Est. completion date: September 23, 2020

Study information

• Verified date: November 2020
• Source: LegoChem Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 23, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 46 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LegoChem Biosciences, Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)