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Drug interaction check: will fluconazole change how BI 425809 works?

NCT ID NCT05076409

Completed Knowledge-focused Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study tested how the antifungal drug fluconazole changes the levels of the experimental drug BI 425809 in the blood. Fifteen healthy men took a single dose of BI 425809 alone, and later took it while also taking fluconazole daily. The goal was to see if fluconazole affects how much BI 425809 stays in the body, which helps guide future dosing in patient studies.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
BI 425809 (Iclepertin) and fluconazole
What this could lead to
If successful, this study will help determine the right dose of BI 425809 when taken with fluconazole, supporting future trials for conditions like schizophrenia.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It only looks at drug levels, not whether the drug works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEALTHY

Contacts and locations

Locations

  • Humanpharmakologisches Zentrum Biberach

    Biberach, 88397, Germany

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