At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
BI 1595043 +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 Single Rising Oral Doses of BI 1595043 (Single-blind, Partially Randomised, Placebo-controlled, Parallel (Sequential) Group Design) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating BI 1595043 and Placebo for Healthy. Completed, enrolled 64 participants across 1 site.
Detailed Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1595043 in healthy male subjects following oral administration of single rising doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartAug 2020
Primary CompletionMar 2021
TodayJul 2026
First PostedJun 19, 2020
Enrollment StartAug 13, 2020
Primary CompletionMar 19, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.0 years ago
Interventions
BI 1595043drug
BI 1595043
Placebodrug
Placebo