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COMPLETED
NCT05076409
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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).

Official title: Effect of Fluconazole on the Pharmacokinetics of a Single Oral Dose of BI 425809 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2021-10-19

Completion Date

2022-01-10

Last Updated

2026-05-04

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

Humanpharmakologisches Zentrum Biberach

Biberach, Germany