Drug level – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Mon, 03 Aug 2026 10:43:01 +0000 en-US hourly 1 https://wordpress.org/?v=7.0.4 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Drug level – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Effect of itraconazole on the pharmacokinetics of BI 1584862 in healthy male volunteers https://clinicaltrials.eu/trial/effect-of-itraconazole-on-the-pharmacokinetics-of-bi-1584862-in-healthy-male-volunteers/ Mon, 03 Aug 2026 10:43:01 +0000 https://clinicaltrials.eu/trial/effect-of-itraconazole-on-the-pharmacokinetics-of-bi-1584862-in-healthy-male-volunteers/ The trial enrolls healthy adult men and examines how a medicine called itraconazole, taken as a liquid, influences the behavior of an experimental drug identified as BI 1584862, which is taken as a small tablet. No specific disease is being treated; the participants are volunteers who are in good health.

The purpose of the study is to find out whether a strong blocker of the body’s CYP3A4 enzyme, which normally helps break down many medicines, changes the amount of the test drug that reaches the bloodstream after a single dose.

Participants will first receive the test drug alone, then after a short interval they will take the enzyme blocker for several days before receiving the test drug again. Blood samples will be collected at various times to see how much of the test drug is present, and the whole process takes place over a few weeks.

]]> Effect of iclepertin on the blood levels of ethinylestradiol and levonorgestrel in healthy premenopausal women https://clinicaltrials.eu/trial/effect-of-iclepertin-on-the-blood-levels-of-ethinylestradiol-and-levonorgestrel-in-healthy-premenopausal-women/ Mon, 03 Aug 2026 10:43:01 +0000 https://clinicaltrials.eu/trial/effect-of-iclepertin-on-the-blood-levels-of-ethinylestradiol-and-levonorgestrel-in-healthy-premenopausal-women/ A group of healthy premenopausal women, meaning women who have not yet reached menopause, will take part in a study that looks at a medication called BI 425809 and a common birth‑control pill known as Microgynon. Microgynon contains two active ingredients, ethinyl estradiol and levonorgestrel, which work together to prevent pregnancy.

The purpose of the study is to find out whether taking BI 425809 changes the way the body handles the contraceptive hormones, a process known as pharmacokinetics, which includes how the drugs are absorbed, distributed, and cleared from the bloodstream.

Participants will first take the birth‑control pill each day for a set time, then they will start taking the study medication alongside the pill. Blood samples will be collected at several points to see how much of the contraceptive hormones are present in the blood while both medicines are being used. The study will end after the planned treatment period is completed.

]]> Study of BI 1810631 (C‑14) oral solution, BI 1810631 (C‑14) IV microtracer, and BI 1810631 tablet to assess absorption and metabolism in healthy men https://clinicaltrials.eu/trial/study-of-bi-1810631-c-14-oral-solution-bi-1810631-c-14-iv-microtracer-and-bi-1810631-tablet-to-assess-absorption-and-metabolism-in-healthy-men/ Mon, 03 Aug 2026 10:42:53 +0000 https://clinicaltrials.eu/trial/study-of-bi-1810631-c-14-oral-solution-bi-1810631-c-14-iv-microtracer-and-bi-1810631-tablet-to-assess-absorption-and-metabolism-in-healthy-men/ The investigation involves a new compound called BI 1810631 that is being tested in healthy adult men. The compound is given in three ways: as a liquid taken by mouth called an oral solution, as a small pill known as a film-coated tablet, and as a very small dose injected into a vein, referred to as an intravenous microtracer. The liquid and the injected dose contain a tiny amount of a radioactive marker labeled C-14 to help track the drug inside the body.

The aim of the study is to understand how the body takes up, breaks down, and removes the drug, including how much of it reaches the bloodstream and how much is eliminated in waste. In the first part, participants receive the oral solution and provide samples of urine and feces over several days. In the second part, participants take the tablet while a microtracer dose is given by injection, and blood is drawn to measure the drug in plasma.

Researchers will calculate the total amount of drug recovered (mass balance), study its metabolism and overall movement through the body (pharmacokinetics), and determine the absolute bioavailability of the tablet form. The analysis includes measuring the overall exposure (AUC) and the highest concentration reached (Cmax) in the blood.

]]> Effect of BI 1015550 on blood levels of nintedanib and pirfenidone in healthy men https://clinicaltrials.eu/trial/effect-of-bi-1015550-on-blood-levels-of-nintedanib-and-pirfenidone-in-healthy-men/ Mon, 03 Aug 2026 10:42:50 +0000 https://clinicaltrials.eu/trial/effect-of-bi-1015550-on-blood-levels-of-nintedanib-and-pirfenidone-in-healthy-men/ The study looks at how taking several doses of a new oral medicine called BI 1015550 may affect the amount of two other medicines, the pill pirfenidone and the capsule nintedanib, that are already used for a lung condition. The purpose of the study is to see whether multiple doses of BI 1015550 change the amount of nintedanib and pirfenidone in the blood.

Healthy adult men will first receive a single dose of each of the two existing medicines, and blood samples will be taken to measure how much of each drug is in the bloodstream. After a short break, the same participants will take a series of daily doses of BI 1015550 for several days, and the same blood tests will be repeated. The study involves only routine blood draws and safety monitoring.

]]> Effect of itraconazole on the blood levels of BI 1815368 after a single oral dose in healthy male subjects https://clinicaltrials.eu/trial/effect-of-itraconazole-on-the-blood-levels-of-bi-1815368-after-a-single-oral-dose-in-healthy-male-subjects/ Mon, 03 Aug 2026 10:42:48 +0000 https://clinicaltrials.eu/trial/effect-of-itraconazole-on-the-blood-levels-of-bi-1815368-after-a-single-oral-dose-in-healthy-male-subjects/ The study involves healthy adult men and examines two medicines: the antifungal drug itraconazole and an experimental compound called BI 1815368. The goal of the trial is to find out whether taking itraconazole changes how much of BI 1815368 appears in the bloodstream after a single dose.

Participants first receive several doses of itraconazole taken by mouth. After this period, they take one dose of BI 1815368, also taken by mouth. Blood samples are collected at various times to measure the amount of the experimental drug that is present. The same participants later take a single dose of BI 1815368 without any itraconazole, and blood is sampled in the same way. By comparing the two situations, researchers can see how itraconazole influences the level of the experimental drug in the blood.

]]> A study to test how BI 1291583 is broken down and removed from the body in healthy men https://clinicaltrials.eu/trial/a-study-to-test-how-bi-1291583-is-broken-down-and-removed-from-the-body-in-healthy-men/ Mon, 03 Aug 2026 10:42:14 +0000 https://clinicaltrials.eu/trial/a-study-to-test-how-bi-1291583-is-broken-down-and-removed-from-the-body-in-healthy-men/ 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.

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