Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study to Assess the Effect of Food on the Pharmacokinetics of CA-4948 in Healthy Male Subjects

This study is an early-stage clinical trial (Phase I) that aims to understand how a new medicine, called CA-4948, is absorbed and used by the body. Specifically, researchers want to see if eating different foods changes how this medicine works in healthy men. This type of study helps scientists learn more about new drugs before they are tested in people who are unwell. The goal is to make sure the medicine is given in the best possible way when it eventually helps patients with blood cancers. It's a fundamental step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Curis Inc.

Enrolment target

Start

04 Mar 2024

Hematologic malignancies

What is this study about?

This study is about a new medicine called CA-4948. Scientists are looking into it as a possible treatment for "hematologic malignancies," which is a medical term for certain types of blood cancer. Before this medicine can be given to people with these conditions, researchers need to understand how it behaves in the human body. This early study is a crucial first step in that process.

The main aim of this particular study is to see how different foods might affect the way CA-4948 is taken in by the body. For example, does taking the medicine with a meal make it work better or worse? Does it stay in the body longer or shorter? Understanding these details is really important because it helps doctors know the best way to give the medicine later on, ensuring it's as effective and safe as possible for patients.

Because this is an early-stage, or "Phase I," study, it involves healthy volunteers rather than patients with blood cancer. This allows researchers to focus purely on how the body handles the drug without other health conditions making it more complicated. The information gathered from this study will help guide future research into CA-4948 and its potential to help those with blood cancers.

Key takeaways

This is an early-stage study for a new blood cancer medicine.
It's looking at how food affects the medicine in healthy men.
Participation involves taking the medicine and having regular health checks.
The study helps scientists find the best way to give the medicine in the future.

Who may be eligible?

This study is looking for healthy men to take part. You must be at least 18 years old to be considered.

Because this is a very early study to understand how a new medicine works in the body, it is only for healthy individuals. If you have any ongoing health conditions or are taking regular medications, you might not be able to join.

The research team will carry out several checks and ask detailed questions about your health to make sure it's safe for you to participate in this specific trial. They need to be sure that nothing else will affect how the medicine works in your body during the study.

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 a man?
Are you 18 years old or older?
Are you generally healthy with no major ongoing medical conditions?
Are you willing to follow specific rules about food and drink during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, CA-4948, sometimes with food, and sometimes without, or with different types of food. The study team would carefully explain the exact schedule. You would have several visits to the study clinic, where you might have blood samples taken to see how much of the medicine is in your body over time. You might also have other check-ups like blood pressure readings and general health assessments.

The total amount of time you would be involved in the study would depend on the specific plan set by the researchers, but early-stage studies often involve short periods of taking the drug and then follow-up visits. You would be given specific instructions on what you can and cannot eat or drink before and during certain parts of the study.

Potential risks and benefits

Potential benefits of participating include helping scientists learn vital information about a new medicine that could one day treat challenging conditions. However, there are no direct health benefits to you as a participant unless specifically stated. Potential risks may include side effects from the experimental medicine, which will be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What kind of illness is CA-4948 for?

CA-4948 is being looked into as a potential treatment for certain types of blood cancer, known as hematologic malignancies.

Why is this study only for healthy men?

This is an early study (Phase I) to understand exactly how the new medicine works in the body. Using healthy volunteers helps researchers see the effects of the medicine clearly without other health problems complicating things.

Do I have to eat certain foods for the study?

Yes, part of the study involves looking at how food affects the medicine. You will be asked to take the medicine with different types of meals or at specific times in relation to food, according to the study plan.

Will I be given the actual medicine for blood cancer?

You will be given the new study medicine, CA-4948, but this study isn't treating a disease. It's investigating how the medicine acts in healthy bodies.

How long will I need to be involved?

The exact duration will be explained by the study team, but typically, these early studies involve a period of taking the medicine and several follow-up clinic visits.