A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550

• Registration Number: NCT06415045
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Study Start: 2024-05-28
• Status Verified: 2024-07
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 1015550 without food, then BI 1015550 with food	BI 1015550	-
BI 1015550 with food, then BI 1015550 without food	BI 1015550	-

Primary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma (Cmax)	Up to day 7
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 day 7

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 day 7

Trial Locations

Locations (1)

CRS Clinical Research Services Berlin GmbH; 🇩🇪 Berlin, Germany