Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737433
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2023-02-10
Brief Title:
Single Dose ADME Study of 14C-Rencofilstat in Healthy Male Subjects
Sponsor:
Hepion Pharmaceuticals Inc
Organization:
Hepion Pharmaceuticals Inc
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None