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

NCT07308652 | Completed Phase 1

• 3 other identifiers: 1434-00212025-523135-19-00U1111-1325-2539
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (1)

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

EXPERIMENTAL

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

Drug: BI 764198; Drug: Itraconazole

Interventions

BI 764198 DRUG

BI 764198

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

Itraconazole DRUG

Itraconazole

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 30, 2025
• Study Start: February 9, 2026
• Primary Completion: March 24, 2026
• Study Completion: April 10, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)