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

NCT05737433 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-10-03

Study results available
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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.

Conditions

  • NASH With Fibrosis

Interventions

DRUG

[14C]-rencofilstat 225mg

radio-labelled 225mg oral dose of rencofilstat

Sponsors & Collaborators

  • Hepion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Litza McKenzie, MD · Quotient Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-05-01
Completion
2023-08-04

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05737433 on ClinicalTrials.gov