CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
BI 1595043drug
Likely dose
BI 1595043 30 milligramfrom 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/NCT04789291
NCT04789291Phase 1Completed
CompareCT.gov

A Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 1595043 as Tablets With and Without Food in Healthy Male Subjects

Boehringer Ingelheim·interventional·Posted Mar 9, 2021·Updated Feb 22, 2024

In Brief

A Phase 1 clinical trial evaluating BI 1595043 for Healthy. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R).

Study Details

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

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 9, 2021
Enrollment StartMay 18, 2021
Primary CompletionAug 7, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.3 years ago

Interventions

BI 1595043drug

Single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet).