NCT05183360

A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Dose and Multiple Rising Oral Doses of BI 706321 in Healthy Japanese Male Subjects and Single Oral Dose of BI 706321 in Healthy Chinese Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses. Part II: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Chinese male subjects following oral administration of single dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 706321	BI 706321, tablet, oral use
DRUG	Placebo	Placebo, tablet, oral use

Timeline

• Start date: 2022-02-07
• Primary completion: 2022-08-12
• Completion: 2024-08-08
• First posted: 2022-01-10
• Last updated: 2025-09-23
• Results posted: 2025-09-23

Locations

1 site across 1 country: Japan