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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

NCT04656288 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-03-22

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-03-15
Completion
2021-03-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04656288 on ClinicalTrials.gov