NCT05183347

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1291583 in Healthy Male Japanese Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1291583	BI 1291583
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-02-04
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2022-01-10
• Last updated: 2025-08-13

Locations

1 site across 1 country: Japan