At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 8 enrolled
Drug / intervention
BI 1015550 +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.
Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1015550 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1015550 in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 1015550 and BI 1015550 mixed with [C-14]-BI 1015550 for Healthy. Completed, enrolled 8 participants across 1 site.
Detailed Summary
This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with \[14C\]-labelled BI 1015550. These data are considered necessary to further support the understanding of the pharmacokinetics of BI 1015550.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedJan 2023
Enrollment StartFeb 2023
Primary CompletionMar 2023
TodayJul 2026
First PostedJan 31, 2023
Enrollment StartFeb 14, 2023
Primary CompletionMar 28, 2023
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.4 years ago
Interventions
BI 1015550drug
Treatment T
BI 1015550 mixed with [C-14]-BI 1015550drug
Treatment R