NCT04011241

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1323495 in the Blood

Relative Bioavailability of a Single Oral Dose of BI 1323495 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, One-way Crossover Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the relative bioavailability of BI 1323495 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test,T) as compared to when given alone as oral single dose (Reference, R).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1323495	Tablet
DRUG	Itraconazole	Oral solution

Timeline

• Start date: 2019-07-24
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2019-07-08
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

1 site across 1 country: Germany