At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 6 enrolled
Drug / intervention
[14C]-rencofilstat 225mgdrug
Likely dose
[14C]-rencofilstat 225mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Early Phase 1 clinical trial evaluating [14C]-rencofilstat 225mg for NASH With Fibrosis. Completed, enrolled 6 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH With Fibrosis
CountriesUnited Kingdom
Collaborators--
Timeline
Early Ph 1CompletedFinished
202420252026
First PostedFeb 2023
Enrollment StartMar 2023
Primary CompletionMay 2023
Study CompletionAug 2023
TodayJul 2026
First PostedFeb 21, 2023
Enrollment StartMar 1, 2023
Primary CompletionMay 1, 2023
Study CompletionAug 4, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.4 years ago
Interventions
[14C]-rencofilstat 225mgdrug
radio-labelled 225mg oral dose of rencofilstat