A study in healthy male volunteers to investigate how the test medicine is taken up, processed, and removed from the body
- Conditions
- Pharmacokinetics, mass balance and metabolite profiles of NRD135S.E1 in healthy adult male volunteersNot Applicable
- Registration Number
- ISRCTN51059297
- Lead Sponsor
- ovaremed AG (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 8
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 kg/m² and <30.0 kg/m² as measured at screening
4. Must be willing and able to communicate and participate in the whole study
5. Must be willing to consume the drug formulation that contains a small amount of alcohol
6. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day )
7. Must provide written informed consent
8. 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 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 of current SARS-CoV-2 infection within 2 weeks of first IMP administration or current ongoing symptoms from previous SARS-CoV-2 infection
4. History of any drug or alcohol abuse in the past 2 years
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 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
9. Male subjects with pregnant or lactating partners
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 have been administered IMP in an ADME study in the last 12 months prior to screening
12. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
13. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed
14. Confirmed positive drugs of abuse test result
15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
16. Evidence of renal impairment at screening, as indicated by an estimated eGFR of <60 mL/min using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation
17. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
18. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
19. Subjects with history of intolerance to alcohol
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 or loss of greater than 400 mL of blood within the previous 3 months
22. Subjects with a haemoglobin lower than the lower limit of normal at screening
23. 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 NRD135S.E1 administration. Exceptions may apply on a case by case basis, if considered not to interf
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rates and routes of elimination of the test medicine from the body, and the ways in which the body processes the test medicine will be assessed by taking whole blood, plasma, urine, faeces and saliva samples for liquid scintillation counting to measure the amount of radioactivity, and to identify breakdown products of the test medicine by liquid chromatography with radio detection and high resolution mass spectrometry, between Day 7 and Day 14. Participants stay may be extended an additional two days and they may need to continue collections of urine and faeces for a few days at home after they have left the ward.
- Secondary Outcome Measures
Name Time Method <br> 1. The pharmacokinetics of the test medicine in plasma after single and repeated doses will be assessed by taking blood samples for LC-MS/MS assay of the test medicine between Day 1 and Day 14.<br> 2. Adverse events (to assess tolerability of the test medicine) will be collected by often asking volunteers how they are feeling, from the start of the trial until follow up.<br> 3. Other safety measures (including vital signs, ECGs and laboratory safety tests) will be assessed by standard phase 1 unit monitoring, at screening, from Day –1 to discharge from the ward<br>