NCT05155306

A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food

Relative Bioavailability of Two Different Tablet Formulations of BI 1358894 Administered in Healthy Subjects in Fasted and Fed State (an Open-label, Randomised, Single-dose, Four-period, Four-sequence Crossover Study)

• 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

To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI 1358894.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1358894, intended Commercial Formulation (iCF) (T)	A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning
DRUG	BI 1358894, Trial Formulation 2 (TFII) (R)	A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.

Timeline

• Start date: 2022-01-14
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2021-12-13
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study