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Pharmacokinetic Study of BI 764198 XX (C‑14) and [4-(6‑aminopyridazin‑3‑yl)piperidin‑1‑yl][5-(4‑fluorophenoxy)-4‑methoxypyridin‑2‑yl]methanone in Healthy Men

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What is this study about?

The study involves healthy adult men and examines a single dose of the investigational drug BI 764198 given as a 40 mg oral solution. The medication is taken by mouth in liquid form and is being evaluated to see how it behaves inside the body.

The purpose of the study is to investigate how the drug is processed in the body. Participants will receive one dose of the oral solution and then provide urine and stool samples over several days while blood samples are taken at set times to measure the amount of drug present. This allows researchers to understand the drug’s pharmacokinetics—how it is absorbed, distributed, broken down into metabolites, and eliminated. By tracking the total amount of radioactivity recovered in urine and feces, the study assesses the mass balance of the drug, which shows what proportion of the dose is excreted and through which routes.

1 baseline assessments

after joining the study, basic health checks are performed to confirm that you are a healthy male volunteer. these checks may include measurements of vital signs, simple blood tests, and a review of medical history.

2 single oral dose of study medication

you will receive one oral dose of bi 764198 xx (c-14) as an oral solution. the dose is 40 mg and is taken only once.

in the arm that uses the microtracer approach, you will also receive a single oral dose of [4-(6-aminopyridazin-3-yl)piperidin-1-yl][5-(4-fluorophenoxy)-4-methoxypyridin-2-yl]methanone as an oral solution. this dose is also 40 mg and taken only once.

3 blood sample collection

after the dose, blood samples will be taken at several time points to measure the amount of the medication and its breakdown products in your bloodstream. samples are collected until the last measurable point, which may be several hours or days after dosing.

4 urine and feces collection

you will be asked to provide all urine and feces you produce after dosing. these collections continue until the study team determines that the total radioactivity from the medication can no longer be measured, which helps assess how the body eliminates the drug.

5 final assessments and study completion

once all required samples have been collected and the measurements are complete, a final health check is performed. after this check you are released from the study.

Who Can Join the Study?

  • Be a male who is in good health, confirmed by a doctor after reviewing your medical history (record of past illnesses), completing a physical examination (a check‑up by a physician), measuring your vital signs such as blood pressure (the force of blood in your arteries) and pulse (heart beats per minute), performing a 12‑lead ECG (a test that records the heart’s electrical activity), and doing routine clinical laboratory tests (blood and urine tests).
  • Be between 18 and 65 years old, inclusive.
  • Have a Body Mass Index (BMI) between 18.5 and 29.9 kg/m². BMI is a simple calculation that compares your weight to your height to assess whether you are underweight, normal weight, or overweight.
  • Provide a signed and dated written informed consent before joining the study. This means you agree in writing after the study has explained its purpose, procedures, risks, and benefits. The consent follows ICH‑GCP (international guidelines for good clinical practice) and local laws.

Who Cannot Join the Study?

  • Any abnormal result in the medical exam (including blood pressure, pulse rate or ECG, which is a test that records the heart’s electrical activity) that the doctor decides is important.
  • Repeated blood pressure readings that are too low or too high: the top number (systolic) must be between 90 and 140 mmHg, the bottom number (diastolic) must be between 45 and 90 mmHg, and the pulse rate must be between 40 and 100 beats per minute.
  • Any laboratory value (such as blood or urine test) that is outside the normal reference range and the doctor considers it clinically relevant.
  • Any other disease that the doctor judges to be important for the study (concomitant disease).
  • Disorders of the stomach or intestines (gastrointestinal), liver (hepatic), kidneys (renal), lungs (respiratory), heart and blood vessels (cardiovascular), how the body uses food (metabolic), immune system (immunological) or hormone system (hormonal).
  • Any additional reasons listed in the study protocol.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Puunffnokbbjjy Rrjoorrt Akzthhlnoe Gvnoz Bhmi Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
02.05.2023

Trial locations

Investigated Drugs:

BI 764198 XX (C-14) is an experimental medicine being studied for the first time in people. In this trial it is taken as a single dose of liquid that you swallow. The purpose of giving this drug is to learn how quickly it is absorbed, how it spreads through the body, how it is broken down, and how it leaves the body. By watching these steps the researchers can understand the basic behavior of the medicine.

[4-(6-AMINOPYRIDAZIN-3-YL)PIPERIDIN-1-YL][5-(4-FLUOROPHENOXY)-4-METHOXYPYRIDIN-2-YL]METHANONE is a specially designed version of the same experimental drug that contains a very small amount of a harmless radioactive marker. It is also taken as a liquid you swallow. The tiny radioactive tag lets scientists track exactly where the drug goes inside the body and how it is processed, giving detailed information about its metabolism and excretion.

Cardiovascular disease – Cardiovascular disease refers to disorders that affect the heart and blood vessels. It often starts with the buildup of fatty deposits in arteries, which narrows them and reduces blood flow. Over time, the reduced flow can cause the heart muscle to work harder, leading to thickening of the heart walls. The condition may also cause blood clots that block vessels, further limiting circulation. As the disease advances, symptoms such as chest discomfort, shortness of breath, or swelling may appear.

Trial ID:
2022-502327-22-00
Protocol code:
1434-0016
Trial Phase:
Human Pharmacology (Phase I) – Other

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