At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)
In Brief
A Phase 1 clinical trial evaluating BI 411034 and Placebo for Healthy. Completed, enrolled 62 participants across 1 site.
Detailed Summary
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses. The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM). Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
Study Details
Timeline
Interventions
Low dose solution for oral administration
Solution for oral administration
Medium dose solution for oral administration
Low dose solution for oral administration
High dose solution for oral administration
High dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
Medium dose solution for oral administration