Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study comparing different RO7269162 capsules and investigating the effect of food on the uptake, breakdown, and elimination of RO7269162 in Healthy Participants

This study is looking into a new medicine called RO7269162. We're inviting healthy adults to take part. The main goal is to compare different types of capsules containing RO7269162. Scientists also want to find out how eating food affects the way your body takes in, processes, and gets rid of the medicine. This kind of research, called 'Human Pharmacology', is an early step in developing new medicines. It helps us understand how the medicine works in the body before it's tested in people who are unwell. This helps ensure the medicine is given safely and effectively if it's used to treat illnesses later on. Your participation would help us learn vital information.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

29 Aug 2025

Not Applicable

What is this study about?

This research study is about a new medicine called RO7269162. At this early stage of development, we invite healthy volunteers to help us understand it better. We want to compare different ways of delivering the medicine, specifically different types of capsules. This helps us work out which capsule form is best absorbed and used by the body.

Another important part of the study is to see if eating food at the same time as taking the medicine changes how your body handles it. For example, some medicines are absorbed better with food, while others might be affected negatively. Understanding this helps doctors know if patients should take the medicine with or without a meal.

This type of study is called 'Human Pharmacology' or a 'Phase 1' study. It's one of the very first stages of testing a new medicine in people. The main purpose is to learn how the medicine works in the body – how it's taken in, broken down, and eventually leaves your system. This helps scientists gather important safety information and work out the right dose before moving on to studies with people who have a specific illness. Your help in this early stage is crucial for developing potential new treatments.

Key takeaways

This study is testing a new medicine (RO7269162) in healthy adults.
It aims to compare different capsule types and see how food affects the medicine.
This is an early stage (Phase 1) study to learn how the medicine works in the body.
Participation involves clinic visits, taking the study medicine, and health checks.
You will be closely monitored for any side effects.
You can stop participating at any time if you change your mind.

Who may be eligible?

If you're thinking about joining this study, you need to be an adult, 18 years old or older. There isn't an upper age limit, so people of many ages can take part as long as they meet other health requirements.

This study is open to both men and women. Because this is an early study to understand how the medicine works in general, it's designed for healthy people. This means you shouldn't have any major ongoing health problems.

Specific details about your health will be checked by the study team. They will ask you questions about your medical history, and you might have some tests to make sure that taking part is safe for you.

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?
Do you consider yourself to be generally healthy?
Are you Male or Female?
Are you able to attend several clinic appointments?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll generally be asked to visit a clinic for several appointments. These visits will involve various checks, such as blood tests, measuring your heart rate and blood pressure, and possibly other tests to see how the medicine is working in your body. You will be given doses of the study medicine, RO7269162, likely at different times to see the effects of different capsules or food. There will be careful monitoring after you take the medicine to see how your body processes it. The total duration of your participation, including follow-up, will be explained in detail by the study team, but these types of studies can involve several clinic visits over a few weeks or months.

Potential risks and benefits

Taking part in a study like this helps advance medical science and could lead to new treatments in the future. However, there are potential risks, as the medicine is new, and you might experience side effects. These can range from mild, like a headache, to more serious, although serious side effects are rare and you will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care, so you are always in control of your participation.

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 RO7269162?

RO7269162 is the name of a new medicine that is being studied for the first time in healthy people.

Why is this study only for healthy people?

This early study helps us understand how the medicine works in a general way in the body before it is tested in people who are unwell. This also helps us understand any common side effects.

Will I be paid to take part?

The study information will explain if there is any payment for your time and travel, as this can vary between studies.

What does 'Human Pharmacology' mean?

It's an early stage of research where scientists study how a new medicine affects the human body – how it's absorbed, used, and cleared out.

How long will I need to be in the study?

The full duration will be explained by the study team, as it varies, but these types of studies often involve several visits over a few weeks or months.