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

NCT06955754 | Completed Phase 1

• 3 other identifiers: 1434-00062024-519615-34-00U1111-1316-1438
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 4 days

Secondary Outcomes (4)

• 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

Study Arms (4)

Treatment sequence A

EXPERIMENTAL

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; Drug: BI 764198, formulation 2; Drug: BI 764198, formulation 3

Treatment sequence B

EXPERIMENTAL

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; Drug: BI 764198, formulation 2; Drug: BI 764198, formulation 3

Treatment sequence C

EXPERIMENTAL

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; Drug: BI 764198, formulation 2; Drug: BI 764198, formulation 3

Treatment sequence D

EXPERIMENTAL

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; Drug: BI 764198, formulation 2; Drug: BI 764198, formulation 3

Interventions

BI 764198, formulation 1 DRUG

BI 764198, formulation 1

Treatment sequence A; Treatment sequence B; Treatment sequence C; Treatment sequence D

BI 764198, formulation 2 DRUG

BI 764198, formulation 2

Treatment sequence A; Treatment sequence B; Treatment sequence C; Treatment sequence D

BI 764198, formulation 3 DRUG

BI 764198, formulation 3

Treatment sequence A; Treatment sequence B; Treatment sequence C; Treatment sequence D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach/Riss, 88397, Germany

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: May 20, 2025
• Primary Completion: June 26, 2025
• Study Completion: July 14, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)