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Completed

NCT Number: NCT07211425

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria apply

Treatment and study plan

BI 3031185

Drug

BI 3031185

Itraconazole

Drug

Itraconazole

Primary outcomes

  1. 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)

    Time frame: Up to Day 13

  2. Maximum measured concentration of BI 3031185 in plasma (Cmax)

    Time frame: 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-∞)

    Time frame: Up to Day 13

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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