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COMPLETED
NCT04656288
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2021-01-15

Completion Date

2021-03-15

Last Updated

2026-07-06

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

SGS Belgium NV Research Unit Stuivenberg

Antwerp, Belgium