MedTrace Logo

A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood

NCT03892616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-28

Study results available
· View outcomes & findings →

Summary

The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1) of BI 1358894 under fed conditions following oral administration and to investigate the effect of food on the exposure with TF2 (TF2a, TF2b).

Conditions

  • Healthy

Interventions

DRUG

BI 1358894 (B)

Tablet formulation 2 (TF2a), fed

DRUG

BI 1358894 (C)

Tablet formulation 2 (TF2a), fasted

DRUG

BI 1358894 (D)

Tablet formulation 2 (TF2b), fed

DRUG

BI 1358894 (E)

Tablet formulation 2 (TF2b), fasted

DRUG

BI 1358894 (A)

Tablet formulation 1 (TF1), fed

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
2019-04-08
Primary Completion
2019-07-03
Completion
2019-07-03

Countries

  • Germany

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 NCT03892616 on ClinicalTrials.gov