At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
BI 425809drug
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.
The Effect of Food on the Pharmacokinetics of a BI 425809 Tablet Formulation Administered as a Single Dose With and Without Food to Healthy Subjects (an Open-label, Randomised, Two-period, Two-sequence Crossover Trial)
In Brief
A Phase 1 clinical trial evaluating BI 425809 for Healthy. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The main objective of this trial is to investigate the potential effect of food on the pharmacokinetics of BI 425809 following administration of the intended Commercial Formulation (iCF) with food (Test treatment, T) and without food (Reference treatment, R).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartOct 2022
Primary CompletionDec 2022
TodayJul 2026
First PostedApr 26, 2022
Enrollment StartOct 25, 2022
Primary CompletionDec 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.2 years ago
Interventions
BI 425809drug
BI 425809