NCT04714073

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood

Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 706321 in Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Design 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

To investigate the pharmacokinetics of a single oral dose of BI 706321 when given alone or in combination with itraconazole.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 706321	Treatment period 1: Single oral dose of 1 film-coated tablet administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) Treatment period 2: On day 1 of period 2 (1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet administered with 240 mL of water after an overnight fast of at least 10 h.
DRUG	Itraconazole	Treatment period 2: Administered as an oral solution formulation once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2.

Timeline

• Start date: 2021-02-11
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2021-01-19
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

1 site across 1 country: Germany