NCT03754959

This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1358894 (Double-blind, Randomised, Placebo-controlled, Parallel-group Design) and Evaluation of Midazolam Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of multiple rising doses over 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1358894	Film-coated tablet
DRUG	Placebo	Film-coated tablet
DRUG	Midazolam	Solution for injection

Timeline

• Start date: 2018-12-18
• Primary completion: 2019-07-22
• Completion: 2019-07-22
• First posted: 2018-11-27
• Last updated: 2025-04-03
• Results posted: 2025-04-03

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study