At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
BI 1265162 +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 Inhaled Doses of BI 1265162 in Healthy Male Subjects in a Randomised, Double Blind, Placebo-controlled Trial
In Brief
A Phase 1 clinical trial evaluating BI 1265162 and Placebo for Healthy. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 1265162 in healthy male subjects following inhalative administration of multiple rising doses. Secondary objectives is the exploration of the pharmacokinetics (PK) including dose proportionality and time dependency of BI 1265162 after multiple dosing
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartJul 2018
Primary CompletionDec 2018
TodayJul 2026
First PostedJul 3, 2018
Enrollment StartJul 11, 2018
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.0 years ago
Interventions
BI 1265162drug
Multiple rising inhaled doses
Placebodrug
Multiple rising inhaled doses