At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
BI 1358894 +2 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.
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)
In Brief
A Phase 1 clinical trial evaluating BI 1358894 and BI 1358894 (C-14) intravenous solution for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartJul 2020
Primary CompletionOct 2020
TodayJul 2026
First PostedJun 11, 2020
Enrollment StartJul 13, 2020
Primary CompletionOct 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.1 years ago
Interventions
BI 1358894drug
Tablet
BI 1358894 (C-14) intravenous solutiondrug
BI 1358894 mixed with \[carbon labelled (C-14)\] BI 1358894
BI 1358894drug
Oral suspension