NCT06791187

A Study in Healthy People to Test Whether BI 1291583 Influences the Amount of Dabigatran in the Body

The Effect of a Single Dose of BI 1291583 on the Pharmacokinetics of a Single Dose of Dabigatran Following Oral Administration in Healthy Adult Male Subjects (an Open-label, 2- Period, Fixed-sequence Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the effect of a single dose of BI 1291583 on the pharmacokinetics of a single dose of dabigatran, an efflux transporter P-glycoprotein (P-gp) substrate.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	dabigatran etexilate	dabigatran etexilate
DRUG	BI 1291583	BI 1291583

Timeline

• Start date: 2025-01-23
• Primary completion: 2025-02-21
• Completion: 2025-03-27
• First posted: 2025-01-24
• Last updated: 2025-08-13

Locations

1 site across 1 country: Germany