At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 66 enrolled
Drug / intervention
BI 474121 tablet +3 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 Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 Administered as Oral Solution and Tablets to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 474121 as Tablet Versus Oral Solution and Tablet With and Without Food (BA Part)
In Brief
A Phase 1 clinical trial evaluating BI 474121 tablet, Placebo tablet, and 2 other interventions for Healthy. Completed, enrolled 66 participants across 1 site.
Detailed Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartJan 2020
Primary CompletionMar 2021
TodayJul 2026
First PostedDec 11, 2019
Enrollment StartJan 9, 2020
Primary CompletionMar 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.6 years ago
Interventions
BI 474121 tabletdrug
BI 474121 tablet
Placebo tabletdrug
Placebo tablet
BI 474121 oral solutiondrug
BI 474121 oral solution
Placebo solutiondrug
Placebo solution