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
NCT number | NCT03492996 |
Study type | Interventional |
Source | LegoChem Biosciences, Inc |
Contact | |
Status | Not yet recruiting |
Phase | Early Phase 1 |
Start date | September 1, 2018 |
Completion date | December 20, 2018 |
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
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.