NCT03747926

This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 705564 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses. A secondary objective is the exploration of the PK including dose proportionality of BI 705564 after single dosing.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 705564	single-rising oral dose
DRUG	Placebo	single-rising oral dose

Timeline

• Start date: 2019-04-05
• Primary completion: 2019-08-12
• Completion: 2019-09-02
• First posted: 2018-11-20
• Last updated: 2021-11-15

Regulatory

• FDA-regulated drug study