Mass balance study of [14C]-REN001 in healthy male subjects
- Conditions
- Primary mitochondrial myopathy (rare genetic diseases that cause muscles to not function properly)Genetic Diseases
- Registration Number
- ISRCTN57533271
- Lead Sponsor
- Reneo Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 6
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 30.0 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 (i.e. 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 defined in the clinical protocol
1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or within 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. Subjects who report to have previously received REN001
4. Evidence of current SARS-CoV-2 infection
5. History of any drug or alcohol abuse in the past 2 years
6. 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)
7. A confirmed positive alcohol breath test at screening or admission
8. Current smokers and those who have smoked within the last 12 months. 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
10. Subjects with pregnant or lactating partners
11. 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
12. Subjects who have been administered IMP in an ADME study in the last 12 months
13. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
14. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed.
15. Confirmed positive drugs of abuse test result
16. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
17. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation
18. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
19. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
20. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
21. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
22. 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 IMP 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 IMP; 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. COVID-19 vaccines are accepted concomitant medications.
23. Failure to satisfy the investigator of fitness to participate for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mass balance recovery of total radioactivity in all excreta (urine and faeces): CumAe and Cum%Ae measured using liquid scintillation counting. This is assessed between Day 1 and Day 13, or later if the radioactivity criteria were not met (including additional collections in the clinical unit and/or home collections).
- Secondary Outcome Measures
Name Time Method