Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects

Summary

This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat (\[14C\] CRV431). It is planned to enroll 6 healthy male subjects in a single group. Each subject will receive a single 225 mg oral dose of \[14C\] CRV431 self-micro emulsifying drug delivery system (SMEDDS) oral emulsion.

Timeline

Start

2023-03-01

Primary completion

2023-05-01

Completion

2023-08-04

Drugs

Indications