At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Relative Bioavailability of BI 1810631 as Two Different Oral Formulations Given as Single Doses and Investigation of the Effects of Food and Multiple-dose Rabeprazole on the Pharmacokinetics of Single-dose BI 1810631 Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Four-way Crossover Trial)
In Brief
A Phase 1 clinical trial evaluating BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF), and 1 other intervention for Healthy. Completed, enrolled 13 participants across 1 site.
Detailed Summary
BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.
Study Details
Timeline
Interventions
BI 1810631 - trial formulation 1 (TF1)
BI 1810631 - new formulation (NF)
Rabeprazole sodium