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

The Effect of Multiple Doses of Itraconazole on the Single-dose Pharmacokinetics of BI 3031185 Following Oral Administration in Healthy Trial Participants (an Open-label, Two-period, Fixed- Sequence Design Study)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07211425

Enrollment

Registered

2025-10-08

Start date

2025-10-08

Completion date

2026-01-21

Last updated

2026-02-04

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

Conditions

Healthy

Brief summary

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.

Interventions

DRUGBI 3031185

BI 3031185

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)), 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 * Further

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to Day 13
Maximum measured concentration of BI 3031185 in plasma (Cmax)	Up to Day 13

Secondary

Measure	Time frame
Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to Day 13

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026