A Study in Healthy People to Test How 2 Different Doses of BI 1291583 Are Taken up in the Body When Given in 3 Different Formulations

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1291583

• Registration Number: NCT06631417
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of two different formulations of BI 1291583 (test formulations) compared to BI 1291583 reference formulation administered at two different dose levels.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-08
• Study Start: 2024-10-22
• Primary Completion: 2025-01-10
• Status Verified: 2025-05
• Study Completion: 2025-05-14
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 1291583 formulation 1 then formulation 2 then formulation 3 (part A)	BI 1291583	-
BI 1291583 formulation 1 then formulation 2 then formulation 3 (part B)	BI 1291583	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)	Up to 22 days
Maximum measured concentration of the analyte in plasma (Cmax)	Up to 22 days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)	Up to 22 days

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany