NCT04065295

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225

A Randomised, Single-blind, Placebo-controlled Trial in Parallel Group Design to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356225 Administered as Oral Solution and Tablets to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Bioavailability Comparison of BI 1356225 as Tablet With and Without Food

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objectives of the SRD part of this trial are to investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects following oral administration of single rising doses. The main objective of the BA part of this trial will be to explore the influence of food on the bioavailability of tablet fasted versus tablet fed

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1356225	Oral Dose
DRUG	Placebo	Oral dose

Timeline

• Start date: 2019-09-09
• Primary completion: 2019-12-23
• Completion: 2019-12-23
• First posted: 2019-08-22
• Last updated: 2022-12-14

Locations

1 site across 1 country: Germany