At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
BI 1595043 +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 1595043 (Double-blind, Randomised, Placebocontrolled, Parallel Group Design) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating BI 1595043, Placebo, and 1 other intervention for Healthy. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The primary objectives of this trial are to investigate safety and tolerability of BI 1595043 in healthy male subjects following administration of multiple rising doses over 14 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartApr 2021
Primary CompletionJan 2022
TodayJul 2026
First PostedMar 9, 2021
Enrollment StartApr 1, 2021
Primary CompletionJan 14, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.3 years ago
Interventions
BI 1595043drug
BI 1595043
Placebodrug
Placebo
Midazolamdrug
Midazolam