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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

NCT06193811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-20

No results posted yet for this study

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

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2024-03-14
Completion
2024-03-14

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193811 on ClinicalTrials.gov