AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A clinical trial to learn about the effects of DAK539 on the blood levels of repaglinide, midazolam, drospirenone, and ethinyl estradiol in people with advanced cancer

This research study is designed to understand how a new investigational medicine called DAK539 interacts with other medicines in the body. Specifically, we'll be looking at how DAK539 affects the levels of drugs like repaglinide (for diabetes), midazolam (for anxiety), and a combination of drospirenone and ethinyl estradiol (often used for birth control) when given to people who have advanced cancer. This is an early-stage study, meaning it's one of the first times DAK539 is being tested in humans to see how it behaves in the body and if it changes how other common medicines work. The aim is to gather important information that could help ensure future treatments are safe and effective.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novartis Pharma AG

Enrolment target

Start

14 Apr 2026

Patients with advanced malignancies

What is this study about?

This study is about a new drug, called DAK539, and how it might affect other common medicines. When you take more than one medicine, sometimes they can interact with each other. This means one drug can change how your body uses another drug, either by making it stronger or weaker, or by changing how quickly your body gets rid of it. This study wants to find out if DAK539 has any of these effects on repaglinide (a diabetes medicine), midazolam (a medicine sometimes used for anxiety or before medical procedures), and drospirenone/ethinyl estradiol (a type of birth control medication).

Doctors need to understand these interactions to make sure that new treatments are safe and work properly. If DAK539 changes how other medicines work, doctors would need to know this so they can adjust doses or choose different medicines to keep you safe and healthy.

This is an early-stage study, which in medical terms is called a "Phase I Human Pharmacology" study. This means it's one of the first times this drug is being studied in people. The main goal at this stage isn't to see if DAK539 treats cancer, but rather to understand how it behaves in the body and if it interacts with other commonly used drugs. This information is a crucial step before the drug can be tested further for its potential to treat cancer.

Key takeaways

This study is for adults (18+) with advanced cancer.
It's testing how a new drug (DAK539) interacts with other common medicines.
The study aims to understand these interactions, not to treat cancer at this stage.
Participation involves taking medicines and having blood tests and health checks.
You will be closely monitored by a medical team.
You can stop participating at any time.

Who may be eligible?

This study is looking for volunteers who are adults, aged 18 years or older. There is no upper age limit, so older adults can take part as long as they meet the other requirements.

To be considered for this study, you must have advanced cancer. This means your cancer has spread or is at a stage where standard treatments might not be working as well.

Both men and women are welcome to participate in this study. The medical team will check other specific health conditions and medicine use to make sure it's safe for you to join and that the study results will be clear.

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?
Have you been diagnosed with advanced cancer?
Are you able to attend study visits regularly?
Are you willing to take the study drug and other specified medications?

Answer every question to see your result.

What does participation involve?

We don’t have detailed information about what taking part in this specific study involves. However, in studies like this, you would typically have several visits to a clinic or hospital. During these visits, you might be given the study drug (DAK539) and the other common medicines (repaglinide, midazolam, or drospirenone/ethinyl estradiol) under careful medical supervision. Doctors and nurses would regularly take blood samples to measure the levels of these medicines in your body. You would also have regular health checks, physical exams, and possibly other tests to monitor how you are feeling and to look for any side effects. The total length of your participation, including any follow-up, would be fully explained by the study team before you decide to join.

Potential risks and benefits

Potential benefits may include contributing valuable information that could help future patients with advanced cancer. You would also receive close medical attention and monitoring throughout the study. However, there is no guarantee that you will personally benefit from taking part. Potential risks include side effects from DAK539 or the other medicines, or from their interaction. These could range from mild to more serious, and the study team will tell you about all known potential risks. It’s important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy
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Unverified
France

Common questions

What is DAK539?

DAK539 is a new drug being investigated. This study is an early step to understand how it works in the body and if it affects other medicines.

Will DAK539 treat my cancer?

The main goal of this particular study is not to treat cancer. It's to learn about how DAK539 interacts with other common medicines in people with advanced cancer.

Why are you looking at other medicines like diabetes drugs or birth control?

We want to see if DAK539 changes how your body handles these common medications. This is important for patient safety and to understand how to use new drugs correctly.

Is this study safe?

All studies have potential risks, but participant safety is the top priority. The research team will explain all known risks, and you will be carefully monitored throughout the study.

Do I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. All study-related care and medicines are typically provided free of charge.