Effect of itraconazole on the blood levels of BI 1815368 after a single oral dose in healthy male subjects

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What is this study about?

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.

1 initial visit and enrollment

after joining the study, a screening visit is scheduled to confirm that the participant is a healthy male and meets the study criteria.

baseline measurements such as vital signs and blood samples are taken before any medication is given.

2 reference period – single dose of bi 1815368

on the designated day, the participant takes one bi 1815368 tablet, which contains a dose of 25 mg.

the tablet is taken by mouth once, without any other medication.

blood samples are collected at several time points after the dose to measure the amount of bi 1815368 in the plasma.

3 washout period (no medication)

a short interval with no study medication is observed to allow the drug from the reference period to clear from the body before the next phase begins.

4 test period – multiple doses of itraconazole followed by single dose of bi 1815368

for several consecutive days, the participant takes itraconazole oral solution, each dose containing 200 mg.

the solution is taken by mouth once daily as instructed.

on the day after the final itraconazole dose, the participant takes another single dose of bi 1815368 (25 mg tablet) together with the itraconazole dose.

blood samples are again collected at multiple time points to compare the exposure of bi 1815368 when itraconazole is present.

5 final assessments and study completion

after the last blood collection, a final check of vital signs and any adverse effects is performed.

the participant is informed that the study procedures are complete.

Who Can Join the Study?

Be a healthy male volunteer, as judged by the doctor after checking your full medical history, a physical exam, vital signs such as blood pressure (BP) and pulse rate (PR), and a 12‑lead ECG (a test that records the heart’s electrical activity).
Be between 18 and 55 years old, including the ages of 18 and 55.
Have a body‑mass‑index (BMI) from 18.5 to 29.9. BMI is a calculation that compares your weight to your height.
Sign and date a written consent form that explains the study, following international and local regulations.

Who Cannot Join the Study?

Any result from the medical examination (including blood pressure, pulse rate or an ECG test) that is not normal and the doctor believes is important. Blood pressure measures the force of blood against artery walls; pulse rate is the number of heartbeats per minute; an ECG records the heart’s electrical activity.
Repeated blood pressure readings where the top number (systolic) is not between 90 and 140 mmHg, the bottom number (diastolic) is not between 50 and 90 mmHg, or the pulse rate is not between 45 and 90 beats per minute. Systolic is the pressure when the heart squeezes; diastolic is the pressure when the heart rests.
Any test result from a lab (such as blood or urine tests) that falls outside the normal reference range and the doctor considers it important. A laboratory value is the number you get from a lab test; the reference range shows what is normal.
Any other disease or health problem that the doctor thinks is important. A concomitant disease means another illness you have at the same time.
Other reasons not listed here may also prevent participation.

Where you can join this trial?

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Site Name	City	Country	Status
Bmrhhjewck Iyuddfuxe Pbeziv Guap &jpea Cnm Ku	Biberach	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	10.08.2023

Trial locations

Investigated Drugs:

Itraconazole

itraconazole is an oral antifungal medicine that was given to the healthy volunteers several times before they took the study drug. In this trial, it was used to see how it might change the way the body processes another medication. The researchers wanted to know if taking itraconazole would increase or decrease the amount of the study drug that appears in the blood.

BI 1815368 is an experimental medicine that has not yet been given a commercial name. Participants took a single dose of this tablet by mouth. The main purpose of the trial was to measure how much of this drug entered the bloodstream and how long it stayed there, both when it was taken alone and when it was taken after the participants had been receiving itraconazole.

Trial ID:

2023-503783-16-00

Protocol code:

1485-0003

Trial Phase:

Human Pharmacology (Phase I) – Other

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Effect of itraconazole on the blood levels of BI 1815368 after a single oral dose in healthy male subjects

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?