NCT03892616

A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood

Relative Bioavailability and Food Effect of a Single Dose of Different Solid Formulations of BI 1358894 Compared to a Single Dose of the Reference Tablet Formulation of BI 1358894 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects (an Open-label, Single-dose, Randomised, Incomplete Blocks Crossover Design Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1) of BI 1358894 under fed conditions following oral administration and to investigate the effect of food on the exposure with TF2 (TF2a, TF2b).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1358894 (B)	Tablet formulation 2 (TF2a), fed
DRUG	BI 1358894 (C)	Tablet formulation 2 (TF2a), fasted
DRUG	BI 1358894 (D)	Tablet formulation 2 (TF2b), fed
DRUG	BI 1358894 (E)	Tablet formulation 2 (TF2b), fasted
DRUG	BI 1358894 (A)	Tablet formulation 1 (TF1), fed

Timeline

• Start date: 2019-04-08
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2019-03-27
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

1 site across 1 country: Germany