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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Litza
McKenzie
+44 (0)3303031000
recruitment@weneedyou.co.uk
Dr
Chris
Galloway
+44 (0)3303031000
rly-4008-101@elevartherapeutics.com
Cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The Sponsor is developing the test medicine (RLY-4008) to treat advanced cancers. Cancer is a disease where abnormal cells in the body grow in an uncontrolled way. Advanced cancer is where the cancer has spread from the original location (metastasised) or has come back after it has been treated (recurred).
This one-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients2. Has known systemic hypersensitivity to the RLY-4008 drug substance, or inactive ingredients3. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active4. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator5. 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 screening6. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening7. Evidence of current SARS-CoV-2 infection within 4 weeks of IMP administration8. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator9. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results10. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation11. Serum phosphate above the upper limit of the reference range at screening12. Serum ALT or bilirubin >1.25 upper limit of reference range at screening13. 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 longer14. 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 study15. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood before IMP administration16. 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 study17. Participants who have taken any medication known to inhibit or induce CYP3A4 enzymes in the 4 weeks before IMP administration18. Participants who have had any vaccine, including the COVID-19 vaccine, in the 8 days before IMP administration19. History of any drug or alcohol abuse in the past 2 years20. 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 admission22. 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 admission23. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months24. Confirmed positive drugs of abuse test result25. Male participants with pregnant or lactating partners26. Participants who are, or are immediate family members of, a study site or sponsor employee27. Failure to satisfy the investigator of fitness to participate for any other reason
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Dr
Litza
McKenzie
+44 (0)3303031000
recruitment@weneedyou.co.uk
Dr
Chris
Galloway
+44 (0)3303031000
rly-4008-101@elevartherapeutics.com
The study is sponsored by Elevar Therapeutics, Inc. and funded by Relay Therapeutics.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
