NCT04567316

A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-radiolabelled BI 1358894	Part 1
DRUG	BI 1358894	Part 2

Timeline

• Start date: 2020-10-19
• Primary completion: 2021-01-10
• Completion: 2021-01-10
• First posted: 2020-09-28
• Last updated: 2025-02-27
• Results posted: 2025-02-27

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study