NCT05428436

A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food

Relative Bioavailability Comparison of BI 1015550 as the Intended Commercial Formulation (iCF) Versus Trial Formulation 2 and iCF With and Without Food Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Three-way Crossover Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the relative bioavailability of BI 1015550 intended Commercial Formulation (iCF) compared with Trial Formulation 2 (TF2) and the effect of food on the pharmacokinetics of BI 1015550 iCF following oral administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Reference (R)	Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
DRUG	Test treatment 1 (T1)	Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
DRUG	Test treatment 2 (T2)	Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.

Timeline

• Start date: 2022-08-15
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2022-06-23
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

1 site across 1 country: Germany