At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
BI 1467335 +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.
A Phase I, Open-label, Single-arm Multiple Dose Trial to Investigate Pharmacokinetics and Absolute Bioavailability of BI 1467335 Administered as an Oral Dose Simultaneously With an Intravenous Microtracer Dose of [C-14] BI 1467335 After Single and Multiple Oral Doses in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 1467335 and BI 1467335 (C-14) intravenous solution for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the absolute bioavailability of BI 1467335 with an intravenous microdose formulation containing labelled \[C-14\] BI 1467335 and an unlabelled oral tablet formulation of BI 1467335 in healthy male subjects. The secondary objective is the evaluation of additional pharmacokinetic parameters following the two treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 2018
Enrollment StartApr 2018
Primary CompletionJun 2018
TodayJul 2026
First PostedMar 30, 2018
Enrollment StartApr 10, 2018
Primary CompletionJun 27, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.3 years ago
Interventions
BI 1467335drug
Film-coated tablet
BI 1467335 (C-14) intravenous solutiondrug
Intravenous solution