At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
BI 443651 +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.
A Phase Ib, Multicentre, Double Blind, Randomized, Two-part Study, First Part Multiple Rising Dose and Second Part Two-way Cross-over, to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of BI 443651 Compared to Placebo Via Respimat® in Healthy Volunteers and CF Subjects.
In Brief
A Phase 1 clinical trial evaluating BI 443651 and Placebo for Cystic Fibrosis. Completed, enrolled 64 participants across 5 sites in 2 countries.
Detailed Summary
The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesGermany, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartFeb 2017
Primary CompletionAug 2018
TodayJul 2026
First PostedNov 29, 2016
Enrollment StartFeb 15, 2017
Primary CompletionAug 29, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.6 years ago
Interventions
BI 443651drug
twice daily
Placebodrug
twice daily