Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A SINGLE-CENTER, OPEN-LABEL, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE ITRACONAZOLE, A STRONG CYP3A INHIBITOR, ON THE PHARMACOKINETICS OF A SINGLE 30 MG DOSE OF RO7269162 IN HEALTHY PARTICIPANTS

This study is an early stage, exploratory research project designed to help scientists understand how a new medicine called RO7269162 behaves in the body. Specifically, we want to see if taking RO7269162 alongside Itraconazole, a common antifungal medicine, changes how RO7269162 is processed. This type of study uses healthy volunteers because it's important to see how the new medicine works in people without other health conditions first. Understanding these interactions is crucial for making sure medicines are safe and work effectively when people need to take more than one at a time. Your participation would help us gather vital information about this new medicine's properties.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

01 May 2024

Not applicable healthy volunteers

What is this study about?

This research study is an important early step in developing a new medicine called RO7269162. Think of it like a detective story: we want to understand exactly what happens to this new medicine once it's inside your body. How quickly does it get absorbed? How long does it stay around? And how does your body get rid of it?

Specifically, we're interested in how RO7269162 acts when a person also takes another common medicine called Itraconazole. Itraconazole is often used to treat fungal infections and can sometimes affect how other medicines are processed by the body. By studying this, we can learn if taking these two medicines together changes how safe or effective RO7269162 might be in the future.

Because this is an early study, we're looking for healthy volunteers. This helps us see the effects of the medicines clearly without other health conditions making it complicated. The information we gather will help doctors understand how to prescribe RO7269162 safely if it becomes available in the future, especially for people who might be taking other medications.

Key takeaways

This is an early-stage study for a new medicine, RO7269162.
It aims to understand how RO7269162 acts in the body, especially with Itraconazole.
The study needs healthy adults (18 years and older).
It involves taking medicines and providing blood samples.
Your participation helps advance medical knowledge for future treatments.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults to take part. This means we're focused on people who don't have any major medical conditions, as this helps us understand the new medicine clearly without other health issues getting in the way.

To be eligible, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older adults may also be able to take part. Both men and women are welcome to participate in this 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 18 years old or older?
Are you generally healthy with no major medical conditions?
Are you able to attend study visits as required?
Are you comfortable with taking study medicines and having blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in a two-part study. You would receive a single dose of the new medicine, RO7269162, at two different times. For one of these times, you would also take doses of Itraconazole for several days before and at the same time as RO7269162. During your visits, blood samples would be taken regularly after you receive the medicine to see how it moves through your body. There would also be check-ups to make sure you are feeling well. The total duration of your involvement, including all visits and follow-up, would be explained fully before you decide to join.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. You might not directly benefit from taking part, but the information gained will help advance medical knowledge, potentially helping others in the future. Potential risks could include side effects from the medicines, discomfort from blood tests, or minor inconveniences during study visits. All potential risks will be thoroughly explained to you, and you will be closely monitored by medical staff. You are free 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 is the new medicine RO7269162 for?

This study is about understanding how RO7269162 works in the body, not what condition it treats. It's an early step in developing a new medicine.

Why do you need healthy volunteers?

Using healthy volunteers helps us see clearly how the new medicine behaves in the body without other health conditions making the results harder to understand.

Will I get paid for taking part?

Information about payment for participation, if any, will be fully explained by the study team before you decide to join.

What is Itraconazole?

Itraconazole is a medicine commonly used to treat fungal infections. In this study, we're using it to see how it might affect the new medicine.

How long will my blood samples be stored?

The study team will explain exactly what happens to any samples taken, how long they are stored, and for what purpose, according to strict rules.