At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Placebo to BI 416970 +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 Oral Doses of BI 416970 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, Investigation of Relative Bioavailability of BI 416970 (Open-label, Randomised, Three-way Cross-over) and Assessment of Safety and Exposure of BI 416970 in CYP2C9 Genotyped Volunteers (Open-label, Single-dose)
In Brief
A Phase 1 clinical trial evaluating Placebo to BI 416970 and BI 416970 for Healthy. Completed, enrolled 60 participants across 1 site.
Detailed Summary
To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartApr 2014
Primary CompletionJun 2014
TodayJul 2026
First PostedMar 21, 2014
Enrollment StartApr 1, 2014
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.3 years ago
Interventions
Placebo to BI 416970drug
single rising doses
BI 416970drug
single rising doses