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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: dabigatran etexilate; Drug: BI 1291583

• Registration Number: NCT06791187
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study Start: 2025-01-23
• Primary Completion: 2025-02-21
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Study Completion: 2025-03-27
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T)	dabigatran etexilate	R=reference treatment (period 1) T=test treatment (period 2)
dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T)	BI 1291583	R=reference treatment (period 1) T=test treatment (period 2)

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to 4 days
Maximum measured concentration of dabigatran in plasma (Cmax)	Up to 4 days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 4 days

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany