A study in healthy volunteers to assess how the test medicine ODM-111 is taken up, broken down and removed from the body when taken by mouth as a tablet, and when given radiolabelled in the form of an oral solution and by short infusion into a vei
- Conditions
- Acute and chronic pain. Study to be conducted in healthy volunteersNot Applicable
- Registration Number
- ISRCTN12728443
- Lead Sponsor
- Orion Corporation (Finland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Male
- Target Recruitment
- 8
1. Must provide written informed consent.
2. Must be willing and able to communicate and participate in the whole study.
3. Aged 30 to 65 years inclusive at the time of signing informed consent.
4. Must agree to and adhere to the contraception requirements defined in the clinical protocol.
5. Males who are healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (haematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
6. Body mass index (BMI) of 18.5 to 32.0 kg/m2 as measured at screening.
7. Weight 55 to 100 kg at screening.
8. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day).
1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator.
4. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
5. Any clinically significant physical examination finding, as judged by the investigator.
6. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed.
7. Subjects who exhibit any first, second or third degree atrioventricular (AV) block at screening.
8. Subjects who have systolic BP <90 mmHg or >140 mmHg or diastolic BP <45 mmHg or >90 mmHg after 5 min in a supine position at screening.
9. Abnormal 12-lead ECG finding of clinical relevance at the screening visit or at pre-dose, (after 5 min rest in supine position), confirmed by a repeat measurement.
10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results.
11. Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation.
12. ALT or aspartate aminotransferase greater than the upper limit of normal (ULN) at screening.
13. 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.
14. 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.
15. Subjects who have been administered IMP in an ADME study in the last 12 months.
16. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.
17. 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 PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise 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.
18. Subjects who have had a COVID 19 vaccine 72 h before admission.
19. History of any drug or alcohol abuse in the past 2 years.
20. 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).
21. A confirmed positive alcohol breath test at screening or admission.
22. Current smokers and those who have smoked within the last 12 mon
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1:<br>Absolute bioavailability (F) of ODM-111 based on AUC(0-inf) of oral administration of ODM-111 compared to radiolabelled IV microtracer dose of ODM-111, adjusted for dose.<br><br>Part 2:<br>Mass balance recovery of total radioactivity in all excreta (urine and faeces) and in urine and faeces separately: Ae, %Ae, CumAe and Cum%Ae and by interval.<br><br>Part 1:<br>Plasma samples for ODM-111 will be taken from pre-dose on Day 1 until 72 h post oral dose on Day 4.<br>Part 2:<br>Mass balance recovery will be measured in urine and faecal samples collected from pre-dose on Day 1 until discharge (up to Day 10), and potentially also including additional home collections if required.
- Secondary Outcome Measures
Name Time Method