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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hepion Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Healthy males

2. Aged 30 to 65 years inclusive at the time of signing informed consent

3. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening

4. Must be willing and able to communicate and participate in the whole study

5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)

6. Must provide written informed consent

7. Must agree to adhere to the contraception requirements

Exclusion Criteria:

1. 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

2. Subjects who are, or are immediate family members of, a study site or sponsor employee

3. Evidence or history of current SARS-CoV-2 infection within 4 weeks prior to study drug administration

4. History of any drug or alcohol abuse in the past 2 years prior to screening

5. 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)

6. A confirmed positive alcohol breath test at screening or admission

7. Current smokers and those who have smoked within the last 12 months prior to screening

8. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission

9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening

10. 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

11. Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening

12. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects known to have Gilbert's syndrome are excluded

13. Confirmed positive drugs of abuse test result

14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results

15. 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

16. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, malabsorptive, neurological or psychiatric disorder, as judged by the investigator

17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

18. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active

19. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood

20. Subjects who have taken known strong or moderate CYP3A4 inducers in the 30 days before IMP administration

21. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before study drug administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with study drug; and if the use of medication does not jeopardize the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study

22. Subjects who have had a COVID-19 vaccine 7 days before dosing