NCT04978506

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1569912 (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) With an Optional Posology (Uptitration) Part (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1569912	BI 1569912
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-09-03
• Primary completion: 2024-07-04
• Completion: 2024-07-04
• First posted: 2021-07-27
• Last updated: 2025-01-13

Locations

1 site across 1 country: Germany