CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
[14C]-radiolabelled BI 1358894 +1 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/NCT04567316
NCT04567316Phase 1Completed
CompareCT.gov

A Phase I, Open-label Trial to Investigate Metabolism and Pharmacokinetics of a Single Dose of [14C] BI 1358894 Administered as Oral Solution (Part 1) and Multiple Doses of BI 1358894 Administered as Film-coated Tablets (Part 2) in Healthy Male Volunteers

Boehringer Ingelheim·interventional·Posted Sep 28, 2020·Updated Feb 27, 2025

In Brief

A Phase 1 clinical trial evaluating [14C]-radiolabelled BI 1358894 and BI 1358894 for Healthy. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894 and its metabolites, total radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of \[14C\] BI 1358894 in Part 1 and to investigate the pharmacokinetics of BI 1358894 and its metabolite(s) following multiple-dose treatment over 21 days with non- radiolabelled compound of BI 1358894 in Part 2.

Study Details

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

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 28, 2020
Enrollment StartOct 19, 2020
Primary CompletionJan 10, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.8 years ago

Interventions

[14C]-radiolabelled BI 1358894drug

Part 1

BI 1358894drug

Part 2