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

NCT07211425 | Completed Phase 1 FDA Drug

• 3 other identifiers: 1516-00042025-520654-10-00U1111-1316-5119
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Drug: BI 3031185; Drug: Itraconazole

Interventions

BI 3031185 DRUG

BI 3031185

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

Itraconazole DRUG

Itraconazole

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

You may not qualify if:

• 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

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: October 2, 2025
• First Posted: October 8, 2025
• Study Start: October 8, 2025
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)