At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 70 enrolled
Drug / intervention
BI 474121 +2 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 Oral Doses of BI 474121 in Young and Elderly Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Evaluation of Midazolam Interaction in Young Healthy Male and Female Subjects (Nested, Open, Fixed-sequence, Intra-individual Comparison)
In Brief
A Phase 1 clinical trial evaluating BI 474121, Midazolam, and 1 other intervention for Healthy. Completed, enrolled 70 participants across 1 site.
Detailed Summary
The main objectives of this trial are to investigate safety and tolerability of BI 474121 in healthy male and female young and elderly subjects following oral administration of multiple rising doses per day over 14 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartOct 2020
Primary CompletionOct 2021
TodayJul 2026
First PostedSep 3, 2020
Enrollment StartOct 6, 2020
Primary CompletionOct 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.8 years ago
Interventions
BI 474121drug
BI474121
Midazolamdrug
Midazolam
Placebodrug
Placebo