At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 96 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.
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets Given Orally Once Daily for 12 Days to Young and Elderly Healthy Male and Female Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Study)(Part 1) and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 After Oral Administration in the Morning Versus Oral Administration in the Evening in Young Healthy Male and Female Volunteers (Randomised, Two-sequence, Open, Two Period, Two-way Cross Over) (Part 2)
In Brief
A Phase 1 clinical trial evaluating BI 425809 and Placebo for Healthy. Completed, enrolled 96 participants across 1 site.
Detailed Summary
The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartJan 2015
Primary CompletionNov 2015
TodayJul 2026
First PostedJan 13, 2015
Enrollment StartJan 15, 2015
Primary CompletionNov 16, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.5 years ago
Interventions
BI 425809drug
Tablets
Placebodrug
Tablets