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A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood

NCT05076409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-04

Study results available
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Summary

The main objective of this trial is to investigate the effect of fluconazole, under steady state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809 alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).

Conditions

  • Healthy

Interventions

DRUG

BI 425809

Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 1. Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 2.

DRUG

fluconazole

Fluconazole orally as hard capsules once daily for 13 days (Day -4 up to Day 9) in period 2.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2022-01-10
Completion
2022-01-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076409 on ClinicalTrials.gov