NCT04102462

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 764198

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 764198 in Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 764198 (Open-label, Randomised, Two-way Cross-over)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of multiple rising doses per day over 14 days and to explore the pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing. In addition, the effect of BI 764198 on the pharmacokinetics of midazolam, given as an oral microdose, will be explored after multiple oral dosing.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 764198	Capsules
DRUG	Matching placebo	Capsules

Timeline

• Start date: 2019-10-29
• Primary completion: 2020-10-08
• Completion: 2020-10-08
• First posted: 2019-09-25
• Last updated: 2020-11-04

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study