A study to test how BI 1291583 is broken down and removed from the body in healthy men

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What is this study about?

This study involves healthy men who do not have any disease. The research will test how a medicine called BI 1291583 moves through and is broken down by the body. The medicine will be given as an oral solution, which is a liquid that is swallowed. The study will use a special version of the medicine that contains a substance called C-14, which is a type of radioactive marker that allows researchers to track where the medicine goes in the body. The purpose of the study is to understand how the body processes this medicine and how much of it leaves the body through urine and stool.

Participants in this study will receive a single dose of BI 1291583 by mouth. After taking the medicine, samples of blood, urine, and stool will be collected at different times. These samples will be tested to measure the amount of medicine and its breakdown products in the body. The researchers will track how the medicine is absorbed, changed by the body, and removed from the body over time. This information will help scientists understand the way the medicine works and how it might be used in future treatments.

The study is described as open-label, which means that both the participants and the researchers will know what medicine is being given. Since this is a phase I trial, it is an early stage of testing that focuses on understanding how the medicine behaves in the body rather than treating a specific disease. The participants will be monitored throughout the study to collect the necessary information about how their bodies handle the medicine.

1 Admission and baseline assessment

Upon joining the study, a complete medical history will be taken and a physical examination will be performed.

Your vital signs will be measured, including blood pressure and pulse rate.

A 12-lead ECG (electrocardiogram, a test that records the electrical activity of your heart) will be performed.

Blood and urine samples will be collected for clinical laboratory tests to assess your health status.

2 Administration of the study medication

You will receive a single oral dose of BI 1291583 containing a small amount of radioactive carbon (C-14).

The medication will be administered as an oral solution that you will take by mouth.

This is a one-time dose, and you will not receive repeated doses during the study.

3 Sample collection period

After taking the medication, blood samples will be collected at specific time points to measure drug levels in your body.

You will be required to collect all urine produced during the study period in provided containers.

You will also be required to collect all faeces (stool) during the study period in provided containers.

These samples will be analyzed to determine how the medication is processed and eliminated from your body.

The collection period will continue until the levels of radioactivity are no longer measurable or have reached a very low level.

4 Monitoring and observation

Throughout the study, your health will be monitored regularly.

Any changes in your condition will be documented and assessed.

The study staff will track the amount of radioactivity eliminated from your body through urine and faeces to understand how completely the medication is removed.

5 End of study assessment

Once sufficient samples have been collected and the medication has been adequately eliminated from your body, a final assessment will be performed.

This may include a physical examination, vital signs measurement, and laboratory tests to ensure your continued health.

Your participation in the study will then be complete.

Who Can Join the Study?

You must be a healthy male person based on the doctor’s evaluation, which includes a complete medical history, a physical examination, checking your vital signs (blood pressure and heart rate), a 12-lead ECG (a test that records the electrical activity of your heart), and laboratory tests of your blood and other body fluids
You must be between 18 and 55 years old
Your BMI (Body Mass Index, which is a measurement that compares your weight to your height) must be between 18.5 and 29.9 kg/m2
You must sign and date a written informed consent form (a document showing you understand and agree to participate in the study)

Who Cannot Join the Study?

Women cannot participate in this study, as it is only open to male subjects
People who are not healthy cannot participate, as the study requires healthy volunteers, which means individuals without any current medical conditions or diseases
Children and elderly people outside the specified age range cannot participate, as the study has specific age requirements for enrollment
People who belong to vulnerable populations cannot participate, which means individuals who may have limited ability to make their own decisions or who need special protection, such as prisoners, people with severe mental disabilities, or those in dependent relationships

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Pwduwwywgyenpl Rlhhukls Abfriglgiy Ghjqa Btpb	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	25.04.2023

Trial locations

Investigated drugs:

Bi 1291583

BI 1291583 is an investigational medication being tested in this trial. It is given as a liquid that you drink (oral solution). In this study, the medication contains a special radioactive marker (called C-14) that helps researchers track how the body processes and eliminates the medication. This allows scientists to understand how the medication moves through the body, how it is broken down, and how it leaves the body through urine and stool.

Healthy – This designation indicates that the study participants do not have any disease or medical condition. Healthy volunteers are individuals who are free from illnesses and do not exhibit symptoms of any disorders. They participate in clinical trials to help researchers understand how medications or treatments work in people without underlying health problems. These participants typically undergo screening to confirm they meet specific health criteria before joining a study. Their involvement helps establish baseline data and safety profiles for new medications. Healthy volunteers play a crucial role in early-phase clinical research.

Trial ID:

2022-502264-20-00

Protocol code:

1397-0016

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study to test how BI 1291583 is broken down and removed from the body in healthy men

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?