CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
BI 1358894 (B) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03892616
NCT03892616Phase 1Completed
CompareCT.gov

Relative Bioavailability and Food Effect of a Single Dose of Different Solid Formulations of BI 1358894 Compared to a Single Dose of the Reference Tablet Formulation of BI 1358894 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects (an Open-label, Single-dose, Randomised, Incomplete Blocks Crossover Design Study)

Boehringer Ingelheim·interventional·Posted Mar 27, 2019·Updated Feb 28, 2025

In Brief

A Phase 1 clinical trial evaluating BI 1358894 (B), BI 1358894 (C), and 3 other interventions for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartApr 8, 2019
Primary CompletionJul 3, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.3 years ago

Interventions

BI 1358894 (B)drug

Tablet formulation 2 (TF2a), fed

BI 1358894 (C)drug

Tablet formulation 2 (TF2a), fasted

BI 1358894 (D)drug

Tablet formulation 2 (TF2b), fed

BI 1358894 (E)drug

Tablet formulation 2 (TF2b), fasted

BI 1358894 (A)drug

Tablet formulation 1 (TF1), fed