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
Overview
- Phase
- Early Phase 1
- Intervention
- [14C]-rencofilstat 225mg
- Conditions
- NASH With Fibrosis
- Sponsor
- Hepion Pharmaceuticals, Inc.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
[14C]-RCF 225mg
\[14C\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose
Intervention: [14C]-rencofilstat 225mg
Outcomes
Primary Outcomes
To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat
Time Frame: 22 Days
Cumulative percentage of total radioactivity recovered after a single oral dose of \[14C\]-rencofilstat.