NCT04426851

A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood

Investigation of Pharmacokinetics and Absolute Bioavailability of BI 1358894 Administered Orally as Tablet Co-administered With an Intravenous Microtracer Dose of [C-14]-BI 1358894 in Healthy Male Volunteers Via a Non-randomised, Open-label, Fixed-sequence Trial (Part 1) Followed by a Randomised, Open-label, Single-dose, Two-period, Two-sequence Cross-over Relative Bioavailability Trial in BI 1358894 Oral Suspension (Part 2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of Part 1 of this trial is to investigate the absolute bioavailability of BI 1358894 with an intravenous microdose formulation containing labelled \[C-14\] BI 1358894 and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects. The main objective of Part 2 of this trial is to investigate the relative bioavailability of BI 1358894 administered as an oral suspension.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1358894	Tablet
DRUG	BI 1358894 (C-14) intravenous solution	BI 1358894 mixed with \[carbon labelled (C-14)\] BI 1358894
DRUG	BI 1358894	Oral suspension

Timeline

• Start date: 2020-07-13
• Primary completion: 2020-10-12
• Completion: 2020-10-12
• First posted: 2020-06-11
• Last updated: 2025-03-30
• Results posted: 2025-03-30

Locations

1 site across 1 country: Netherlands