Cancer Cancer
Conditions
Interventions
This is a non-randomised, open-label study. This healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. Volunteers will be given a radio
Sponsors
Elevar Therapeutics, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Aged 30 to 55 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements defined in the clinical protocol and have no desire to father children in the next 6 months. 5. Healthy males 6. Body mass index (BMI) of 18.0 to 31.0 kg/m2 as measured at screening 7. Body weight of =50 kg as measured at screening 8. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day)
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 2. Has known systemic hypersensitivity to the RLY-4008 drug substance, or inactive ingredients 3. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 4. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator 5. History of any retinal disorder (e.g. tears, detachment, retinitis pigmentosa) or symptoms suggestive of such disorder (e.g. history of floaters, distorted vision or blind spots) or history of significant corneal disorder (e.g. corneal ulcer, dry eyes requiring treatment) as assessed by the investigator or delegate at screening 6. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 7. Evidence of current SARS-CoV-2 infection within 4 weeks of IMP administration 8. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator 9. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results 10. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of 1.25 upper limit of reference range at screening 13. Participants 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. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood before IMP administration 16. Participants 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 participant; and if the use of medication is not considered to interfere with the objectives of the study 17. Participants who have taken any medication known to inhibit or induce CYP3A4 enzymes in the 4 weeks before IMP administration 18. Participants who have had any vaccine, including the COVID-19 vaccine, in the 8 days before IMP administration 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 an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of mass balance measured using urine and faecal samples taken from Day 1 up to Day 17, or until mass balance criteria are met 2. Metabolite profiling and structural identification measured using blood, urine and faecal samples taken from Day -1 up to Day 17, or until mass balance criteria are met | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Identification of the chemical structure of each metabolite measured using blood, urine and faecal samples taken from Day -1 until Day 17, or until mass balance criteria are met 2. Evaluation of whole blood:plasma concentration ratios for total radioactivity measured using blood samples taken from Day 1 until Day 15 3. Safety and tolerability measured using the incidence of adverse events and serious adverse events, and changes from baseline for vital signs, electrocardiograms and laboratory safety tests from Day -1 until discharge from the study 4. Pharmacokinetic parameters measured using blood samples taken from Day 1 until Day 15 | — |
Countries
England, United Kingdom
Contacts
Public ContactChris Galloway
Outcome results
None listed