At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 57 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 Single Rising Inhaled Doses of BI 1265162 in Healthy Male Volunteers in a Partially Randomised, Single Blind, Placebo-controlled Trial
In Brief
A Phase 1 clinical trial evaluating BI 1265162 and Placebo for Healthy. Completed, enrolled 57 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 single rising doses. Secondary objective is the exploration of the pharmacokinetics (PK) of BI 1265162 after single dosing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartNov 2017
Primary CompletionMar 2018
TodayJul 2026
First PostedNov 21, 2017
Enrollment StartNov 23, 2017
Primary CompletionMar 5, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.6 years ago
Interventions
BI 1265162drug
Single rising dose groups
Placebodrug
Single rising dose groups