Official Title

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)

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.

Sponsor

Boehringer Ingelheim

Recruitment Status

ACTIVE_NOT_RECRUITING

Study Objective

TREATMENT

ClinicalTrials.gov ID

NCT06955754

Additional Identification number

Last Update Posted

2025-06-11

Study Completion (Actual)

2025-06-27

Study Record Versions

Contacts and Locations

facility: Humanpharmakologisches Zentrum Biberach
city: Biberach/Riss
zip: 88397
country: Germany

Conditions

Healthy

TargetDisease

ProductName

IsActiveControl

IsControlDrug

IsPlacebo

ControlDrug

-

Intervention / Treatment

type: DRUG
name: BI 764198, formulation 1
description: BI 764198, formulation 1
armGroupLabels: [Treatment sequence A, Treatment sequence B, Treatment sequence C, Treatment sequence D]

type: DRUG
name: BI 764198, formulation 2
description: BI 764198, formulation 2
armGroupLabels: [Treatment sequence A, Treatment sequence B, Treatment sequence C, Treatment sequence D]

type: DRUG
name: BI 764198, formulation 3
description: BI 764198, formulation 3
armGroupLabels: [Treatment sequence A, Treatment sequence B, Treatment sequence C, Treatment sequence D]

Intervention

Study Type

INTERVENTIONAL

Phase

PHASE1

Allocation

RANDOMIZED

Interventional Model

CROSSOVER

Subject Blind

Arm Label

Arm Type

label: Treatment sequence A
type: EXPERIMENTAL
description: 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
interventionNames: [Drug: BI 764198, formulation 1, Drug: BI 764198, formulation 2, Drug: BI 764198, formulation 3]

label: Treatment sequence B
type: EXPERIMENTAL
description: 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
interventionNames: [Drug: BI 764198, formulation 1, Drug: BI 764198, formulation 2, Drug: BI 764198, formulation 3]

label: Treatment sequence C
type: EXPERIMENTAL
description: 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
interventionNames: [Drug: BI 764198, formulation 1, Drug: BI 764198, formulation 2, Drug: BI 764198, formulation 3]

label: Treatment sequence D
type: EXPERIMENTAL
description: 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
interventionNames: [Drug: BI 764198, formulation 1, Drug: BI 764198, formulation 2, Drug: BI 764198, formulation 3]

NumberOfInterventionGroups

0

GroupEnrollment

Target Number of Participant

0

InstitutionLocation

InstitutionPhoneNumber

Study Site

Location Countries

Countries of recruitment

Study Start (Actual)

2025-05-20

Arm Description

Inclusion and Exclusion Criteria

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.

minimum age

18 Years

maximum age

55 Years

Standard ages

ADULT

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

NO

Enrollment (Actual)

16

Original Enrollment (Actual)

0

Final Enrollment Number

0

FinalSubjectSelectionDate

AnalysisTargetGroup

DemographicInformation

Primary Outcome Measures

measure: 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)
timeFrame: up to 4 days

measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 4 days

Secondary Outcome Measures

measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 4 days

measure: 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)
timeFrame: up to 4 days

measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity, dose normalized (AUC0-∞, norm)
timeFrame: up to 4 days

measure: Maximum measured concentration of the analyte in plasma, dose normalised (Cmax, norm)
timeFrame: up to 4 days

PrimaryEndpointResult

Primary Completion Date (Actual)

2025-06-26

ClinicalTrialResultSummary

Telephone

Address

Name

Title

Telephone

Affiliation