A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food

Relative Bioavailability of Three Different Oral Formulations of BI 764198 Including the Investigation of Food Effect on the Tablet Formulation in Healthy Male and Female Subjects (an Open-label, Randomised, Four-way Crossover Trial)

This trial aims to investigate the relative bioavailability of three different oral formulations of BI 764198 and how this is influenced by food.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 764198, formulation 1; Drug: BI 764198, formulation 2; Drug: BI 764198, formulation 3

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach/Riss, Germany, 88397
    • Humanpharmakologisches Zentrum Biberach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
• Signed and dated written informed consent in accordance with the International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence A; T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state	Drug: BI 764198, formulation 1; BI 764198, formulation 1; Drug: BI 764198, formulation 2; BI 764198, formulation 2; Drug: BI 764198, formulation 3; BI 764198, formulation 3
Experimental: Treatment sequence B; T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state	Drug: BI 764198, formulation 1; BI 764198, formulation 1; Drug: BI 764198, formulation 2; BI 764198, formulation 2; Drug: BI 764198, formulation 3; BI 764198, formulation 3
Experimental: Treatment sequence C; T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast	Drug: BI 764198, formulation 1; BI 764198, formulation 1; Drug: BI 764198, formulation 2; BI 764198, formulation 2; Drug: BI 764198, formulation 3; BI 764198, formulation 3
Experimental: Treatment sequence D; R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state	Drug: BI 764198, formulation 1; BI 764198, formulation 1; Drug: BI 764198, formulation 2; BI 764198, formulation 2; Drug: BI 764198, formulation 3; BI 764198, formulation 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum measured concentration of the analyte in plasma (Cmax)	up to 4 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	up to 4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 4 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point, dose normalized (AUC0-tz, norm)	up to 4 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity, dose normalized (AUC0-∞, norm)	up to 4 days
Maximum measured concentration of the analyte in plasma, dose normalised (Cmax, norm)	up to 4 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): July 14, 2025

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1434-0006; 2024-519615-34-00 (Ctis); U1111-1316-1438 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No