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COMPLETED
NCT06041438
PHASE1

A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The main objective of this trial is to investigate the effect on the exposure of BI 1584862 in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as compared to BI 1584862 when given alone as oral single dose (Reference, R).

Official title: Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1584862 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Design Study)

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2023-09-29

Completion Date

2023-11-10

Last Updated

2026-06-03

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BI 1584862

One dose with 240 mL of water after an overnight fast of at least 10 h

DRUG

Itraconazole

200 mg daily after an overnight fast of at least 9 h for several consecutive days

Locations (1)

Humanpharmakologisches Zentrum Biberach

Biberach, Germany