Deferred registration - ICON Clinical (UK) Limited/Newcastle Upon Tyne Hospitals NHS Foundation Trust Code: BP45361
This clinical trial (code BP45361) is an early Phase 1 study conducted with ICON Clinical and Newcastle Upon Tyne Hospitals NHS Foundation Trust. In the UK, the Health Research Authority sometimes grants permission to delay publishing the full medical details of early-stage trials. This delay, known as a deferred registration, is often used to protect sensitive research information. Because the details are deferred, the specific medical condition, medication, and full entry rules have not yet been made public. However, the study will involve adults aged between 40 and 75 years. Phase 1 trials are the first step in testing treatments in humans, focusing mainly on safety and dosage. Full information will be published on the trial register once the deferral period ends. If you are interested in research, speak with your doctor about available trials.
At a glance
What is this study about?
This study is a Phase 1 clinical trial involving ICON Clinical and Newcastle Upon Tyne Hospitals NHS Foundation Trust. Phase 1 trials are an essential early stage in developing new medicines. Their main goal is to find out if a new treatment is safe for people to take, discover what side effects it might cause, and see how the body absorbs and clears it.
You might notice that information about the exact health condition or treatment being tested is not yet available. In the UK, the Health Research Authority allows researchers to temporarily pause the release of full trial information. This deferral is normal practice for certain early-stage trials, often to protect commercial information or new scientific discoveries before patents are finalised.
Even though the public record is limited right now, the trial must still follow strict UK safety and ethics standards. Regulators review the study thoroughly to protect patient safety before any testing begins. Complete details about the study, what it aims to treat, and how it works will be added to the public record as soon as the approved delay ends.
Key takeaways
- This is an early-stage Phase 1 trial linked to Newcastle Upon Tyne Hospitals.
- Full details about the condition and treatment are temporarily delayed under UK regulations.
- The study involves adults aged between 40 and 75 years.
- Full information will be updated publicly once the official delay expires.
- Taking part in any NHS clinical trial is always voluntary.
Who may be eligible?
At this stage, the only confirmed eligibility criteria are age and sex. The trial is open to both men and women who are between 40 and 75 years old.
The specific medical requirements—such as whether you need to have a particular condition or be a healthy volunteer—have not yet been shared publicly due to the official deferral.
Once the delay period expires, the full list of medical conditions, medications, and lifestyle factors will be published so people can see if they qualify.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged between 40 and 75 years old.
- You are able to travel to Newcastle for hospital appointments if needed.
- You are comfortable waiting for full medical criteria to be published before applying.
- You are open to participating in an early-stage (Phase 1) safety trial.
What does participation involve?
Because this is a Phase 1 study, participation usually involves very thorough health checks. If you join, you would likely start with a screening visit where doctors check your blood pressure, take blood and urine samples, and record your heart's rhythm (an ECG). You would then receive the study treatment under careful medical supervision. Some Phase 1 studies require short stays in a hospital research clinic or frequent day visits so doctors can monitor you closely. The study team will provide a detailed Patient Information Sheet explaining the exact visit schedule, tests, and total time commitment before you agree to take part.
Potential risks and benefits
Locations (2)
- The Newcastle upon Tyne Hospitals NHS Foundation TrustCity onlyNewcastle upon Tyne, England
- University Hospitals Plymouth NHS TrustCity onlyDevon, England
Common questions
Why are the full details of this trial not shown?
The UK Health Research Authority has agreed to delay publishing full details. This is common in early research to protect sensitive scientific data, but the study still follows all standard UK safety rules.
What is a Phase 1 trial?
A Phase 1 trial is an early test of a treatment in a small group of people. It helps researchers find safe doses and understand how the body responds to the treatment.
Can I sign up for this trial today?
Because the detailed medical criteria are not yet public, recruitment details are limited. You can check back once the deferral ends or talk to your doctor about other local trials.
Where is this study taking place?
The trial is linked to Newcastle Upon Tyne Hospitals NHS Foundation Trust and ICON Clinical in the UK.
Will taking part affect my normal medical treatment?
No. Taking part in research is entirely voluntary. If you choose not to join or decide to leave early, your regular NHS care will remain exactly the same.
How to find out more
- Clinical Trial Accountable
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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