A Study in Healthy People to Test How Itraconazole Influences the Amount of BI 3031185 in the Blood

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2026-01-21

Brief Summary

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The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics of a single dose of BI 3031185 following oral administration.

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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 1584862 (R), then BI 1584862 + itraconazole (T)

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

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Itraconazole

Intervention Type DRUG

Itraconazole

Interventions

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BI 3031185

Intervention Type DRUG

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)), and 12-lead electrocardiogram (ECG)
* 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, Pulse rate (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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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