NCT05380947

A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1810631 - trial formulation 1 (TF1)	BI 1810631 - trial formulation 1 (TF1)
DRUG	BI 1810631 - new formulation (NF)	BI 1810631 - new formulation (NF)
DRUG	Rabeprazole sodium	Rabeprazole sodium

Timeline

• Start date: 2022-06-23
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2022-05-19
• Last updated: 2025-11-04
• Results posted: 2025-11-04

Locations

1 site across 1 country: Germany