A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood

Boehringer Ingelheim

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole; Drug: BI 764198

Study type: Interventional

Funder types: Industry

Identifiers

NCT07308652

2025-523135-19-00 (Registry Identifier)

U1111-1325-2539 (Registry Identifier)

1434-0021

Details and patient eligibility

About

The purpose of this study is to find out whether a medicine called itraconazole changes the amount of another medicine called BI 764198 in the blood. Some people may take more than 1 medicine at a time. Therefore, it is important to understand how medicines influence each other. This study will help us learn more about how BI 764198 works.

Enrollment: 14 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg / m^2 (inclusive)
• Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 1 patient group

BI 764198 (R), then BI 764198 + itraconazole (T)

Experimental group

Description:

R=Reference treatment (Period 1) T=Test treatment (Period 2)

Treatment:

Drug: BI 764198

Drug: Itraconazole