At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 58 enrolled
Drug / intervention
BI 1026706 +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, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)
In Brief
A Phase 1 clinical trial evaluating BI 1026706 and Placebo to BI 1026706 for Osteoarthritis. Completed, enrolled 58 participants across 1 site.
Detailed Summary
* To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses * To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients * The assessment of pharmacodynamics in OA patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionOct 2014
Study CompletionOct 2014
TodayJul 2026
First PostedApr 30, 2014
Enrollment StartMay 28, 2014
Primary CompletionOct 1, 2014
Study CompletionOct 21, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.2 years ago
Interventions
BI 1026706drug
Multiple Rising Doses (oral solution, tablet)
Placebo to BI 1026706drug
Multiple Rising Doses (oral solution / tablet, identical to active treatment)