At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
BI 425809 +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 Study to Investigate the Effects of Donepezil on the Pharmacokinetics of BI 425809 and Vice Versa in Healthy Male and Female Subjects (Open-label, Two-treatment, Two-period, One Fixed Sequence Cross-over Design)
In Brief
A Phase 1 clinical trial evaluating BI 425809 and Donepezil for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The main objective of Part 1of this trial is to investigate the effect of co-administration of multiple doses of donepezil on the single-dose pharmacokinetics of BI 425809 in healthy subjects. In Part 2 the main objective is the investigation of the effect of co-administration of multiple doses of BI 425809 on the single-dose pharmacokinetics of donepezil in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartApr 2019
Primary CompletionAug 2019
TodayJul 2026
First PostedApr 5, 2019
Enrollment StartApr 12, 2019
Primary CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.2 years ago
Interventions
BI 425809drug
Film coated tablet
Donepezildrug
Film coated tablet