A Study to Estimate the Effect of Multiple Doses of Carbamazepine on the PK of Single Dose Vepdegestrant in Healthy Adult Participants
This early-stage study, called a "Phase I human pharmacology study," is investigating how a medication often used for seizures and nerve pain, called carbamazepine, can affect a new experimental drug for breast cancer, named vepdegestrant. Researchers want to understand how the body processes vepdegestrant when carbamazepine is also taken. This is important to ensure that future patients receiving vepdegestrant get the correct dose, especially if they are also taking other medicines. The study is being conducted in healthy adult volunteers to safely gather this important information about drug interactions.
At a glance
What is this study about?
This study is about understanding how different medicines interact within the body. Imagine your body is a factory that processes medicines. Some medicines can speed up or slow down how your body deals with other medicines. This particular study is looking at two medicines: carbamazepine, which is used for conditions like epilepsy (seizures) and nerve pain, and vepdegestrant, which is a new experimental drug being developed to treat a specific type of breast cancer called ER+/HER2 positive breast cancer.
The main goal is to see how multiple doses of carbamazepine affect a single dose of vepdegestrant. This helps researchers learn if taking carbamazepine changes how much vepdegestrant stays in your body, how quickly it's removed, or how strong its effect might be. This information is crucial because it helps doctors know what dose of vepdegestrant might be safe and effective for patients, especially if those patients are also taking carbamazepine or similar medicines.
Because this is an early-stage study (called "Phase I"), it's being done in healthy volunteers. This allows researchers to gather detailed information about how the drugs behave in the body without the complications of a current illness. The results will help guide the development of vepdegestrant, making sure that when it eventually reaches patients with breast cancer, it can be used as safely and effectively as possible.
Key takeaways
- This is an early-stage study investigating how two medicines interact.
- It checks how carbamazepine (for seizures/pain) affects vepdegestrant (a new breast cancer drug).
- Healthy adult volunteers are needed for this research.
- The aim is to understand drug processing in the body for future patient safety.
- Participation involves taking both drugs, blood tests, and clinic visits.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should generally be in good health with no major ongoing medical conditions.
You must be at least 18 years old, and there is no upper age limit, so adults of any age can be considered. Both men and women are welcome to participate.
Specific details about your health and any medicines you currently take will be checked by the study team to make sure it's safe for you to join. For example, if you are currently taking carbamazepine or other medicines, they will assess if you can safely participate.
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 in good health?
- Are you willing to take both study medications?
- Are you able to attend all required clinic visits and follow-ups?
What does participation involve?
If you take part in this study, you will be given both carbamazepine and vepdegestrant. You will take carbamazepine for several days and then receive a single dose of vepdegestrant. Throughout the study, you'll have regular visits to the clinic, which will involve things like blood tests to measure the levels of the drugs in your body. You might also have other checks, such as ECGs (heart tracings) and vital sign measurements (like blood pressure and heart rate). The study will involve a screening visit, several dosing periods, and follow-up appointments. The total duration of your participation will depend on the study's specific schedule, but these types of studies typically involve a few weeks of active participation and some follow-up.
Potential risks and benefits
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Common questions
What is ER+/HER2 positive breast cancer?
This is a specific type of breast cancer where the cancer cells have certain features (receptors) that respond to hormones (ER+) and also have high levels of a protein called HER2. These features help doctors choose the best treatments.
What does 'PK' mean in the study title?
PK stands for 'pharmacokinetics.' It's a scientific term that describes how your body handles a medicine – how it's absorbed, distributed, processed, and removed. This study is looking at the 'PK' of vepdegestrant.
Why is this study being done in healthy people?
Early-stage studies like this often use healthy volunteers to safely find out how a new drug behaves in the body without other illnesses or medications complicating the results. This makes it easier to understand the drug's basic effects and interactions.
What is carbamazepine used for?
Carbamazepine is a medication typically prescribed for conditions like epilepsy (seizures) and certain types of nerve pain. It's quite a common medicine.
Will I get the new breast cancer drug for free?
While you will receive the experimental drug vepdegestrant as part of the study, this is not a treatment study for breast cancer. It's a research study to understand how drugs interact, and you must be healthy to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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