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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

NCT ID: NCT06955754

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-07-14

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

BI 764198, formulation 1

Intervention Type DRUG

BI 764198, formulation 1

BI 764198, formulation 2

Intervention Type DRUG

BI 764198, formulation 2

BI 764198, formulation 3

Intervention Type DRUG

BI 764198, formulation 3

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

Group Type EXPERIMENTAL

BI 764198, formulation 1

Intervention Type DRUG

BI 764198, formulation 1

BI 764198, formulation 2

Intervention Type DRUG

BI 764198, formulation 2

BI 764198, formulation 3

Intervention Type DRUG

BI 764198, formulation 3

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

Group Type EXPERIMENTAL

BI 764198, formulation 1

Intervention Type DRUG

BI 764198, formulation 1

BI 764198, formulation 2

Intervention Type DRUG

BI 764198, formulation 2

BI 764198, formulation 3

Intervention Type DRUG

BI 764198, formulation 3

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

Group Type EXPERIMENTAL

BI 764198, formulation 1

Intervention Type DRUG

BI 764198, formulation 1

BI 764198, formulation 2

Intervention Type DRUG

BI 764198, formulation 2

BI 764198, formulation 3

Intervention Type DRUG

BI 764198, formulation 3

Interventions

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BI 764198, formulation 1

BI 764198, formulation 1

Intervention Type DRUG

BI 764198, formulation 2

BI 764198, formulation 2

Intervention Type DRUG

BI 764198, formulation 3

BI 764198, formulation 3

Intervention Type DRUG

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanpharmakologisches Zentrum Biberach

Biberach/Riss, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2024-519615-34-00

Identifier Type: CTIS

Identifier Source: secondary_id

U1111-1316-1438

Identifier Type: REGISTRY

Identifier Source: secondary_id

1434-0006

Identifier Type: -

Identifier Source: org_study_id

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