NCT06193811

A Study in Healthy People to Compare Two Different Tablets of BI 685509 and to Test How Food and Esomeprazole Influence the Amount of BI 685509 in the Blood

Relative Bioavailability of Two Different Tablet Formulations of BI 685509 and Investigation of the Effects of Food and Esomeprazole on the Pharmacokinetics of BI 685509 Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Four-way Crossover Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate: * the relative bioavailability of Avenciguat (BI 685509) TF2 (Reference, R) vs. Avenciguat (BI 685509) iCF (Test 1, T1) tablets under fasted conditions * the relative bioavailability of Avenciguat (BI 685509) iCF tablets under fasted (T1) and fed (Test 2, T2) conditions * the relative bioavailability of Avenciguat (BI 685509) iCF tablets given alone (T1) and together with esomeprazole (Test 3, T3) under fasted conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Avenciguat (BI 685509) (intended commercial formulation (iCF))	Avenciguat (BI 685509) (intended commercial formulation (iCF))
DRUG	Avenciguat (BI 685509) (trial formulation 2 (TF2))	Avenciguat (BI 685509) (trial formulation 2 (TF2))
DRUG	esomeprazole	esomeprazole (Nexium mups)

Timeline

• Start date: 2024-01-16
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2024-01-05
• Last updated: 2024-03-20

Locations

1 site across 1 country: Germany