A study to investigate the effect of capivasertib on the pharmacokinetics of oral dextromethorphan (CYP2D6) in healthy participants
When people take more than one medicine, the drugs can sometimes affect each other. This study is looking at an investigational medicine called capivasertib alongside dextromethorphan, a common ingredient found in cough syrups. The liver uses special proteins, called enzymes, to break down and clear medicines from the body. Dextromethorphan is processed by a specific enzyme known as CYP2D6. Researchers want to see whether capivasertib slows down or speeds up this process. Because this is an early-stage safety study, it involves healthy adult volunteers rather than patients with a specific illness. Participants will take the study medicines and have regular blood tests so scientists can measure drug levels over time. The results will help doctors know whether people taking capivasertib in the future need adjusted doses of other common medicines.
At a glance
What is this study about?
Many medicines are broken down and cleared from the body by the liver. To do this, the liver relies on natural tools called enzymes. Sometimes, one medicine can stop these enzymes from working normally, causing another medicine to build up in the body or leave too quickly. This study is designed to check whether a medicine called capivasertib interferes with a specific liver enzyme known as CYP2D6.
To test this, researchers are using dextromethorphan, a medicine often found in over-the-counter cough remedies. Dextromethorphan is widely used in clinical research as a 'probe drug'. Because scientists already know exactly how a healthy liver handles dextromethorphan, measuring its levels in the blood shows clearly whether capivasertib alters the enzyme's normal activity.
This research matters because capivasertib is being developed to treat certain types of cancer. Cancer patients often need to take several different prescription drugs at the same time, including pain relievers, anti-sickness tablets, and heart medicines. Understanding drug interactions now ensures doctors can prescribe capivasertib safely in the future without causing unexpected side effects.
Because this trial focuses strictly on how the body processes these medicines, it is carried out with healthy volunteers. Healthy participants provide a clean baseline, allowing researchers to measure drug levels without the influence of other illnesses or long-term treatments.
Key takeaways
- The study tests how the body breaks down capivasertib and a common cough medicine ingredient.
- It helps scientists discover whether capivasertib could interact with other everyday medicines.
- Open to healthy adult volunteers aged 18 and over.
- Participation involves taking study medicines and having regular blood tests to check drug levels.
- There is no direct medical benefit, but findings help protect future patients.
Who may be eligible?
This study is open to healthy men and women aged 18 and older. Because the goal is to see how a healthy body handles the study medicines, volunteers must be in good general health with no significant ongoing medical conditions.
You may not be able to take part if you take regular prescription medicines, herbal remedies, or certain over-the-counter drugs, as these can interfere with liver enzymes and spoil the test results. Women who are pregnant, planning to become pregnant, or breastfeeding will also not be eligible, to protect the baby's safety.
The trial team will carry out a thorough health check before you join. This usually includes a physical examination, heart tests, and routine blood and urine samples to make sure it is safe for you to take part.
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.
- I am aged 18 or older.
- I consider myself to be in good overall health.
- I am not currently taking regular prescription medicines or herbal supplements.
- I am not pregnant, planning a pregnancy, or breastfeeding.
- I am able to attend appointments and spend time at a clinical research centre.
What does participation involve?
Taking part in this study usually involves an initial screening visit, a short stay at a specialist clinical research unit, and a follow-up check. During the study, you will take single doses of dextromethorphan on its own and together with capivasertib, usually as tablets or liquid swallowed with water. Staff will take small blood samples at set times over several hours or days to measure how much medicine is in your bloodstream. You will also have your heart rate, blood pressure, and general wellbeing monitored closely. The entire study, including visits and follow-up, typically takes several weeks to complete.
Potential risks and benefits
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Common questions
Why is this trial being done in healthy people?
Healthy volunteers have normal organ function and take few or no other medicines. This allows scientists to see exactly how the body handles the study drug without other health issues confusing the results.
What is dextromethorphan?
Dextromethorphan is a standard ingredient used in many common cough syrups. In research, it is safely used in controlled doses to test how well a specific liver enzyme is working.
Will taking part hurt?
The main physical discomfort comes from having blood samples taken using a small needle, which can cause brief pinching or minor bruising.
Will I be paid for my time?
Phase 1 studies with healthy volunteers usually provide payment to compensate you for your time, travel, and any inconvenience. The trial team can provide exact details.
Can I leave the study early if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw from the study at any point, and your decision will always be respected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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