RecruitingPHASE1INTERVENTIONAL

A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants

This research study aims to understand how a new medicine, pelabresib, behaves in the body when taken with other common medications. Specifically, we're looking at how its levels change when healthy volunteers take it alongside phenytoin (used for epilepsy) or itraconazole (an antifungal). The main goal is to see how these drugs affect pelabresib's journey through the body and if its levels go up or down. We also want to check for any side effects and make sure it's safe when combined. This information is important for future use of pelabresib.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

02 Sep 2026

Estimated completion

15 Nov 2026

Healthy Participants

What is this study about?

Imagine your body as a busy factory that processes medicines. This study is like checking how a new product, pelabresib, moves through that factory when other products are also being made. We're especially interested in how two commonly used medicines – phenytoin (often used for epilepsy) and itraconazole (an antifungal medicine) – might speed up or slow down the processing of pelabresib.

Understanding these interactions is really important. If one medicine makes another leave the body too quickly, it might not work as well. If it makes it stay in the body too long, it could lead to more side effects. This early-stage study in healthy volunteers helps us predict how pelabresib might behave when people eventually need to take it with other medications. It helps us understand the best and safest way to use pelabresib in the future.

This study will help doctors and patients know what to expect when pelabresib is prescribed, making sure it works effectively and safely. It's a crucial step in developing new medicines.

Key takeaways

This study investigates how a new drug, pelabresib, interacts with two common medicines.
It aims to understand how pelabresib's levels change in the body when taken with phenytoin or itraconazole.
The study also checks the safety of these drug combinations in healthy volunteers.
Participation involves taking pelabresib alone and then with phenytoin or itraconazole in different study periods.
Your health will be closely monitored with regular checks and blood tests.
Your involvement helps gather important information for the future safe use of pelabresib.

Who may be eligible?

To join this study, you need to be a healthy man or a woman who cannot become pregnant, aged between 18 and 55. You should be in generally good health, which will be checked through medical exams, blood tests, and heart checks (ECGs).

You'll also need to have a healthy body weight for your height (your Body Mass Index, or BMI, should be between 18.5 and 29.9), weigh at least 50 kg, and have normal blood pressure, pulse, and temperature. You must be able to understand and follow the study instructions, and be willing to give your written permission to take part.

There are reasons you wouldn't be able to join, such as having a history of serious heart problems, kidney, liver, or lung disease, or any significant ongoing medical conditions. If your blood tests show unusual results, or if you have any problems with your kidneys or bladder, you would not be able to 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 between 18 and 55 years old?
Are you a man, or a woman who cannot get pregnant?
Do you feel generally healthy, with no major ongoing medical conditions?
Is your body weight within a healthy range (BMI 18.5-29.9, and at least 50 kg)?
Are you able to understand and follow study instructions?
Do you have a normal heart check (ECG) and normal blood and kidney tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study is divided into two main parts. Each part involves two separate times when you'll receive medication.

In the first part, you'll first take a single dose of pelabresib on its own. Then, after a break, you'll take pelabresib again, this time with several doses of phenytoin (an epilepsy drug). In the second part, you'll again start with a single dose of pelabresib on its own. After a break, you'll then take pelabresib with several doses of itraconazole (an antifungal drug).

Throughout these periods, you'll have regular blood tests to check the levels of pelabresib and the other medicines in your body. We'll also monitor your health closely with regular check-ups, including physical exams, vital signs (like blood pressure and pulse), and ECGs. The total time you'll be involved in the study will be explained in detail before you agree to participate.

Potential risks and benefits

Taking part in this study means you're helping us learn important information about new medicines, which could benefit many people in the future. However, there are potential risks, as with any medication. You might experience side effects from pelabresib, phenytoin, or itraconazole, or from the combination of these drugs. While we monitor your health very closely, some side effects could be unexpected or unpleasant. Because this is an early-stage study in healthy volunteers, there is no direct medical benefit to you from taking these medicines. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care. All procedures and potential risks will be fully explained to you before you make any decision.

Locations (1)

Novartis Investigative Site
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is pelabresib?

Pelabresib is a new medicine being studied. This research helps us understand how it works and interacts with other drugs, but it's not yet available for general use.

Why is this study done in healthy people?

Studies in healthy volunteers help us understand how a new medicine behaves in the body without the complications of other illnesses. It’s a first step to ensure safety and understand basic drug interactions.

What are phenytoin and itraconazole?

Phenytoin is a medicine often used to treat epilepsy. Itraconazole is a medicine used to treat fungal infections. We are using these to see how they affect pelabresib.

Will I receive any direct health benefits?

No, this study is for research purposes, and you will not receive any direct health benefits from taking the study medications, as you are a healthy volunteer.

What if I experience side effects?

The study team will carefully monitor you for any side effects throughout your participation. You should report any concerns immediately to the study staff.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.