NCT04866160

A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1291583 qd Versus Placebo in Healthy Male and Female Subjects for 4 Weeks (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD relationship.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1291583	BI 1291583
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-05-17
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2021-04-29
• Last updated: 2025-08-13

Locations

1 site across 1 country: Germany