NCT06255340

A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3031185 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3031185 as Tablet With and Without Food in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 3031185	BI 3031185
DRUG	Placebo matching BI 3031185	Placebo

Timeline

• Start date: 2024-03-11
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2024-02-13
• Last updated: 2024-11-13

Locations

1 site across 1 country: Germany