NCT05737433

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

An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Rencofilstat in Healthy Male Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hepion Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, open-label, non-randomized, single period, single dose study in healthy male subjects designed to assess the mass balance recovery, pharmacokinetics (PK), metabolite profile and metabolite identification of rencofilstat. It is planned to enroll a single cohort of 6 subjects. All subjects will receive a single 225 mg oral dose of \[14C\]-rencofilstat, as a SMEDDS oral emulsion in the fasted state. Subjects will undergo preliminary screening procedures for the study at the screening visit (Day -28 to Day -2). Subjects will be admitted in the evening on the day before dosing (Day-1). Whole blood, plasma, urine and feces samples will be collected at regular intervals for PK analysis, total radioactivity analysis, metabolite profiling, mass balance and safety as applicable, from pre-dose to discharge from the clinical unit. Urine and feces samples may be collected at return visits or home visits if mass balance criteria have not been met by a subject.

Conditions

• NASH With Fibrosis

Interventions

Type	Name	Description
DRUG	[14C]-rencofilstat 225mg	radio-labelled 225mg oral dose of rencofilstat

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-05-01
• Completion: 2023-08-04
• First posted: 2023-02-21
• Last updated: 2024-10-03
• Results posted: 2024-10-03

Locations

1 site across 1 country: United Kingdom