NCT04656288

A Study in Healthy Men to Test if Different Formulations of BI 764198 With or Without Food Influence the Amount of BI 764198 in the Blood

A Two-part Phase I Trial Investigating the Relative Bioavailability and Food Effect of Different Oral Formulations of BI 764198 in Healthy Subjects (an Open-label, Single-dose, Randomised, Crossover Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

BI 764198 is intended to be used in patients hospitalized for COVID-19 at risk of respiratory complications. The present trial will investigate the relative bioavailability of BI 764198 administered as capsules versus tablets in a first part, and the relative bioavailability and food effect of four oral formulations: the newly developed tablet formulation under fed and fasted conditions as well as suspension from capsules and suspension from tablets in a second part.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 764198 - Formula A	BI 764198
DRUG	BI 764198 - Formula B	BI 764198
DRUG	BI 764198 - Formula C	BI 764198
DRUG	BI 764198 - Formula D	BI 764198

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2020-12-07
• Last updated: 2021-03-22

Locations

1 site across 1 country: Belgium