NCT03793621

This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 730357 Are Taken up in the Body and How Well They Are Tolerated

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 730357 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the safety and tolerability of BI 730357 in Japanese healthy male subjects following oral administration of single rising doses. Secondary objectives are the explorations of the pharmacokinetic(s) (PK), including dose proportionality as well as investigation of linearity of BI 730357 after single dose administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 730357	single rising oral dose
DRUG	Placebo	single rising oral dose

Timeline

• Start date: 2019-01-21
• Primary completion: 2019-04-26
• Completion: 2019-04-26
• First posted: 2019-01-04
• Last updated: 2023-07-12
• Results posted: 2023-07-12

Locations

1 site across 1 country: Japan