RecruitingPHASE1INTERVENTIONAL

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women

This study is looking at a new medicine called BI 3031185. Researchers want to understand how safe it is, what side effects it might have, and how the body processes it. They will test different doses in healthy men and women. The study is split into two parts. Part A focuses on healthy men, while Part B includes both healthy men and women who cannot get pregnant. This is a very early stage of testing for a new medicine, an important step before it can be studied in people with illnesses.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

100

Start

07 Apr 2025

Estimated completion

07 Oct 2026

Healthy

What is this study about?

This study is about a new medicine, code-named BI 3031185. When a new medicine is developed, the first step is often to test it in healthy volunteers. This helps researchers understand how the medicine behaves in the body before giving it to people who are unwell. In this study, they want to find out if BI 3031185 is safe, what side effects it might cause, and how much of it the body absorbs, uses, and gets rid of. This is called 'pharmacokinetics', which is a fancy way of describing how the medicine travels through your body. By testing different amounts (doses) of the medicine, they can work out the best dose to use in future studies.

This study is divided into two sections. In the first section, called Part A, only healthy men will take part. In the second section, Part B, both healthy men and healthy women will be included. For women to participate, they must be unable to get pregnant (for example, if they have had certain operations or have gone through menopause). The main goal is to check safety and how the body handles the medicine in these different groups.

Taking part in studies like this is really important for developing new medicines. It helps scientists gather crucial information carefully and safely, making sure that future research can be done as effectively as possible. It's a key step in helping new treatments reach the people who might need them one day.

Key takeaways

This is an early-stage study testing a new medicine called BI 3031185.
It aims to check the medicine's safety and how the body handles it at different doses.
Healthy men and healthy women who cannot get pregnant can participate.
Participation involves health checks and taking the study medicine (or a placebo).
It's a crucial step in developing new treatments.
Your health and safety would be closely monitored throughout.

Who may be eligible?

To join this study, you need to be a healthy man or, for part of the study, a healthy woman who cannot get pregnant. You'll need to have a full health check-up, including a physical exam, blood tests, and an ECG (a heart tracing) to make sure you're in good health.

For men, you need to be between 18 and 50 years old for Part A, or between 18 and 55 years old for Part B. Your Body Mass Index (BMI) should be between 20 and 29.9, and you should weigh at least 60 kg (about 9 stone 6 pounds).

For women, you need to be between 18 and 55 years old and not able to get pregnant. This could be because you've had certain operations (like a hysterectomy) or have definitely gone through menopause. If you have high or low blood pressure, an unusual heart rate, or any other health issues that the study doctor thinks are important, you might not be able to take part.

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 generally healthy adult?
Are you a man, or a woman who cannot get pregnant?
Are you between 18 and 55 years old?
Is your weight and Body Mass Index (BMI) within healthy limits?
Do you have a clean bill of health after a medical check-up?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have a thorough health check to make sure you are suitable for the study. If you qualify, you will receive different doses of the study medicine, BI 3031185, or a placebo (a dummy medicine with no active ingredients). Some participants will also receive a standard medicine called Midazolam for comparison. You will likely have multiple visits to the clinic for various tests, which may include physical examinations, blood pressure and heart rate checks, ECGs, and blood tests to see how the medicine is working in your body. We don't have the exact number of visits or the total length of the study from this summary, but these types of studies often involve several days or weeks of monitoring and follow-up.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to the development of new medicines that could help people in the future. You will also receive careful medical monitoring. However, there are also risks, such as potential side effects from the study medicine, or discomfort from blood tests and other procedures. Some participants will receive a placebo, meaning they won't get the active drug. Your safety and well-being are a top priority, and you will be closely monitored by medical staff. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Charité Research Organisation GmbH
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is BI 3031185?

It's a new medicine that is being tested for the first time in people. We don't know what it will be used for yet, as this study is just looking at its safety.

What is a 'healthy volunteer'?

A healthy volunteer is someone who doesn't have any major medical conditions and is generally in good physical and mental health according to a doctor's check-up.

Why include a placebo?

A placebo is a dummy medicine with no active ingredients. It helps researchers understand the real effects of the new medicine by comparing how people feel when they take the new medicine versus when they take nothing or a dummy pill.

What does 'non-childbearing potential' mean for women?

It means women who cannot get pregnant. This includes women who have had certain surgical procedures (like a hysterectomy) or have gone through menopause.

Will I know if I'm getting the real medicine or the placebo?

Typically, in studies like this, participants don't know whether they are receiving the active medicine or the placebo. This helps ensure the results are unbiased and accurate.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

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