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

The Effect of Multiple Doses of Itraconazole on the Single-dose Pharmacokinetics of BI 764198 Following Oral Administration in Healthy Male Trial Participants (an Open-label, Non-randomised, Two-period, Fixed-sequence Design Study)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07308652

Enrollment

Registered

2025-12-30

Start date

2026-02-09

Completion date

2026-04-10

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGBI 764198

BI 764198

DRUGItraconazole

Itraconazole

Study design

Allocation

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Participants cross over from reference treatment (R, Period 1) to test treatment (T, Period 2) (two periods, fixed sequence)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time curve of BI 764198 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to Day 5 (Period 1 and Period 2)
Maximum measured concentration of BI 764198 in plasma (Cmax)	Up to Day 5 (Period 1 and Period 2)

Secondary

Measure	Time frame
Area under the concentration-time curve of BI 764198 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to Day 5 (Period 1 and Period 2)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026