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

NCT05737433 | Completed Early Phase 1 Results

• 1 other identifier: HEPA-CRV431-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

NASH With Fibrosis

Keywords

Nonalcoholic Steatohepatitis; NASH; NAFLD

Outcome Measures

Primary Outcomes (1)

• To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat

  Cumulative percentage of total radioactivity recovered after a single oral dose of \[14C\]-rencofilstat.

  22 Days

Study Arms (1)

[14C]-RCF 225mg

EXPERIMENTAL

\[14C\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose

Drug: [14C]-rencofilstat 225mg

Interventions

[14C]-rencofilstat 225mg DRUG

radio-labelled 225mg oral dose of rencofilstat

Also known as: CRV431

[14C]-RCF 225mg

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males
• Aged 30 to 65 years inclusive at the time of signing informed consent
• Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
• Must be willing and able to communicate and participate in the whole study
• Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
• Must provide written informed consent
• Must agree to adhere to the contraception requirements

You may not qualify if:

• Subjects who have received any investigational treatment in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
• Subjects who are, or are immediate family members of, a study site or sponsor employee
• Evidence or history of current SARS-CoV-2 infection within 4 weeks prior to study drug administration
• History of any drug or alcohol abuse in the past 2 years prior to screening
• Regular alcohol consumption in males \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
• A confirmed positive alcohol breath test at screening or admission
• Current smokers and those who have smoked within the last 12 months prior to screening
• A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
• Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening
• Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects known to have Gilbert's syndrome are excluded
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• Evidence of renal impairment at screening, as indicated by an estimated eGFR of \<60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation

Sponsors & Collaborators

• Hepion Pharmaceuticals, Inc.: lead

Study Sites (1)

Quotient Sciences

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

CRV-431

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Jill Greytok
• Organization: Hepion Pharmaceuticals Inc

jgreytok@hepionpharma.com

732-902-4000

Study Officials

• Litza McKenzie, MD

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label, non-randomized, single period, and single dose

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: August 4, 2023
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-06

Locations

GB (1)