A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 425809

• Registration Number: NCT05347004
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the potential effect of food on the pharmacokinetics of BI 425809 following administration of the intended Commercial Formulation (iCF) with food (Test treatment, T) and without food (Reference treatment, R).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Study Start: 2022-10-25
• Primary Completion: 2022-12-28
• Study Completion: 2022-12-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 425809 fed state (Test, T) then BI 425809 fasting state (Reference, R)	BI 425809	-
BI 425809 fasting state (Reference, R) then BI 425809 fed state (Test, T)	BI 425809	-

Primary Outcome Measures

Name	Time	Method
Maximum measured concentration of BI 425809 in plasma (Cmax)	Up to 10 Days
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to 10 Days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 10 Days

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany