An open-label, prospective, randomised, cross-over trial to assess the pharmacokinetics of an amorphous formulation of sorafenib in mesoporous magnesium carbonate (DPH001) compared to Nexavar® (sorafenib) in healthy volunteers
This research is looking into a new formulation of a cancer drug called sorafenib. Sorafenib is currently used to treat specific types of cancer, such as liver cancer (hepatocellular carcinoma), kidney cancer (renal cell carcinoma), and a type of thyroid cancer (differentiated thyroid carcinoma). This study, which is in its early stages (Phase I), aims to compare how the new version of sorafenib, called DPH001, is absorbed and used by the body. This will be done by comparing it with the existing drug, Nexavar® (sorafenib), in healthy volunteers. The main goal is to understand if the new formulation could be a better way to deliver this important medication.
At a glance
What is this study about?
This study is about a cancer medicine called sorafenib. This medicine is prescribed for certain types of cancer, including a serious liver cancer (hepatocellular carcinoma), a type of kidney cancer (renal cell carcinoma), and a specific kind of thyroid cancer (differentiated thyroid carcinoma).
Researchers have developed a new way to make and deliver sorafenib, called DPH001. They want to see how this new version works inside the body compared to the sorafenib medicine that is currently available (known as Nexavar®). To do this, they will give both versions to healthy volunteers and carefully measure how the medicine is absorbed, how long it stays in the body, and how it is processed.
This is an early-stage study, often called a 'Phase I' trial. These trials are very important because they help us understand if a new medicine or a new way of giving a medicine is safe and works as expected before testing it in people who are unwell. By learning more about DPH001 in healthy volunteers, researchers hope to see if it could be a better or more effective option for patients in the future.
Key takeaways
- This study is testing a new version of a cancer drug called sorafenib.
- It aims to see how the new drug works in the body compared to the current one.
- Healthy volunteers are needed for this early-stage research.
- The study focuses on liver, kidney, and thyroid cancers.
- You must be 18 or older to take part, with no upper age limit.
- Both men and women can participate in the study.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.
Both men and women are welcome to participate in this research. The study needs a mix of people to get a clearer picture of how the new medicine works.
The researchers will also have other health checks to make sure it's safe for you to take part. Being healthy is important for this type of study, as it helps them understand the medicine's effects without other health conditions getting in the way.
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.
- Are you 18 years old or older?
- Are you generally healthy?
- Are you comfortable having regular health checks and blood tests?
- Are you able to commit to several study visits?
- Do you understand this is a study for healthy volunteers, not for treating cancer?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to check if you are suitable. If you qualify, you would then have several planned visits to a clinic. During these visits, you would be given either the new study medicine (DPH001) or the existing sorafenib. These would be given in a specific order over time. You would have blood samples taken regularly to see how the medicine is absorbed and processed by your body. You would also have other health checks, like blood pressure and heart rate measurements, to make sure you are well. After taking the medicine, there would be follow-up checks to monitor your health. The total time you would be involved in the study would depend on the exact schedule, but it involves multiple visits and periods of observation.
Potential risks and benefits
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Common questions
What is sorafenib?
Sorafenib is a medicine used to treat certain types of cancer, like liver, kidney, and a specific thyroid cancer.
Why are you studying this in healthy people?
Early stage studies often test new medicines in healthy volunteers to understand how they work in the body and look for initial safety before giving them to patients who are unwell.
Will I get the new medicine or the old one?
This study is 'cross-over,' meaning you will likely receive both the new medicine (DPH001) and the old one (Nexavar®) at different times, so researchers can compare them.
Will I know which medicine I'm getting?
This is an 'open-label' study, which typically means both you and the study team will know which medicine you are receiving at any given time.
How long will I be involved in the study?
The study involves multiple visits and follow-up, and the specific duration will be explained by the study team before you join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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