NCT06393127

A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body

Bioequivalence of the BI 1015550 High Dose Formulation C2 and the BI 1015550 High Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nerandomilast	One dose of Formulation C2 (Test treatment - T) administered with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.
DRUG	Nerandomilast	One dose of Formulation C1 - phase 3 formulation (Reference treatment - R) administered with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.

Timeline

• Start date: 2024-06-04
• Primary completion: 2024-09-10
• Completion: 2024-09-10
• First posted: 2024-05-01
• Last updated: 2025-12-01
• Results posted: 2025-12-01

Locations

1 site across 1 country: Germany