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A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood
Sponsor: Boehringer Ingelheim
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
BI 1584862
One dose with 240 mL of water after an overnight fast of at least 10 h
Itraconazole
200 mg daily after an overnight fast of at least 9 h for several consecutive days
Locations (1)
Humanpharmakologisches Zentrum Biberach
Biberach, Germany