연구제목

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)

연구요약

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

연구의뢰자

Boehringer Ingelheim

연구모집현황

ACTIVE_NOT_RECRUITING

임상시험의 목적

TREATMENT

ClinicalTrials.gov 등록번호

NCT06955754

추가 연구 번호

최신갱신일

2025-06-11

연구종료일

2025-06-27

연구 버전 기록

실시기관명

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

연구대상 상태/질환

Healthy

대상질환

제품명(코드명)

활성대조약 여부

대조약 여부

위약 여부

대조약

-

중재/치료

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]

중재 방법

연구종류

INTERVENTIONAL

임상시험단계

PHASE1

배정

RANDOMIZED

중재모형

CROSSOVER

눈가림대상자

중재군명

중재군 유형

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]

중재군 수

0

중재군 별 설명 및 등록 환자수

중재군 목표대상자 수

0

기관소재지

실시기관 전화번호

연구참여기관

국가

환자모집국가

최초 연구대상자 등록일

2025-05-20

상세내용

대상자 선정 및 제외기준

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.

참여 가능한 연령 하한

18 Years

참여 가능한 연령 상한

55 Years

참여 가능한 표준 연령

ADULT

대상자 포함기준 성별

ALL

건강인 참여 여부

NO

실제 대상자수

16

기존 목표대상자 수(실제)

0

최종 연구대상자 수

0

최종 시험대상자 선정일

시험대상자 > 분석대상군

시험대상자 > 인구학적 정보

주요결과변수

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

보조결과변수

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

주요 평가 > 1차 평가변수 결과

최종 주평가변수 수집 완료일

2025-06-26

임상시험결과요약

연구책임자 전화번호

연구책임자 주소

연구실무담당자 성명

연구실무담당자 직위

연구실무담당자 전화번호

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