NCT03492996

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: Male
• Age: 19 Years – 46 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-21
• Primary completion: 2020-08-03
• Completion: 2020-09-23
• First posted: 2018-04-10
• Last updated: 2021-03-12

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study