At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
BI 207127 +4 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.
Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Female and Male Subjects. Randomised, Placebo Controlled, Single-blind, Three-period Crossover Phase-I-study With Moxifloxacin as Positive Control
In Brief
A Phase 1 clinical trial evaluating BI 207127, BI 207127 placebo, and 3 other interventions for Healthy. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionJan 2014
TodayJul 2026
First PostedOct 18, 2013
Enrollment StartOct 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.7 years ago
Interventions
BI 207127drug
Medium dose oral administration
BI 207127 placebodrug
Faldaprevir placebodrug
Faldaprevirdrug
Medium dose oral administration
Moxifloxacin (Avalox®)drug