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

NCT ID: NCT07308652

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-09

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

BI 764198

Intervention Type DRUG

BI 764198

Itraconazole

Intervention Type DRUG

Itraconazole

Interventions

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BI 764198

BI 764198

Intervention Type DRUG

Itraconazole

Itraconazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Site Status

Countries

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Germany

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2025-523135-19-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1325-2539

Identifier Type: REGISTRY

Identifier Source: secondary_id

1434-0021

Identifier Type: -

Identifier Source: org_study_id