NCT03782987

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 730357 in the Blood

Relative Bioavailability of a Single Oral Dose of BI 730357 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 730357 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 730357	0 mg BI 730357 tablet orally on Day 1
DRUG	Itraconazole	20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-03-11
• Completion: 2019-03-11
• First posted: 2018-12-20
• Last updated: 2023-07-12
• Results posted: 2023-07-12

Locations

1 site across 1 country: Germany