A Study in Japanese Healthy Men to Test How Well Different Doses of BI 3031185 Are Tolerated and a Study in Japanese Healthy Women to Test Whether BI 3031185 Influences the Amount of a Contraceptive in the Blood
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of BI 3031185 in Japanese Healthy Male Trial Participants (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Multiple Doses of BI 3031185 on Pharmacokinetics of a Single Dose of a Combination of Drospirenone and Ethinylestradiol (Oral Contraceptive) in Japanese Healthy Female Trial Participants (Non-randomised, Open-label, Fixed Sequence Design)
Single dose (SD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of single dose.
Multiple doses (MD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of multiple doses.
Oral contraceptives (OC) part: The main objective of this trial is to investigate the effect of multiple oral doses of BI 3031185 on pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) (YAZ®) in Japanese healthy female trial participants.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Boehringer Ingelheim
- 전화번호: 1-800-243-0127
- 이메일: clintriage.rdg@boehringer-ingelheim.com
연구 장소
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Fukuoka, Fukuoka, 일본, 813-0017
- Fukuoka Mirai Hospital
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연락하다:
- Boehringer Ingelheim
- 전화번호: 05050508862
- 이메일: nippon@bitrialsupport.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion criteria:
Single dose (SD) and multiple doses (MD) part: Healthy male trial participant 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 Oral contraceptives (OC) part: Women of non-childbearing potential (WONCBP) who meet postmenopausal or surgically sterilised according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause.
- Surgically sterilised (including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- SD and MD part: Age of 18 to 45 years (inclusive) OC part: Age of 18 to 64 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
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 139 mmHg, diastolic blood pressure outside the range of 40 to 89 mmHg, or pulse rate outside the range of 45 to 99 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: SD part: BI 3031185
SD = Single dose
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BI 3031185
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실험적: SD Part: Placebo matching BI 3031185
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Placebo matching BI 3031185
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실험적: MD part: Midazolam and BI 3031185
MD = Multiple doses
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미다졸람
다른 이름들:
BI 3031185
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실험적: MD Part: Midazolam and Placebo matching BI 3031185
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미다졸람
다른 이름들:
Placebo matching BI 3031185
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실험적: OC part: YAZ® and BI 3031185
OC = Oral contraceptives
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BI 3031185
YAZ®
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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SD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
기간: Up to 29 days
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SD = Single dose
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Up to 29 days
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MD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
기간: Up to 47 days
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MD = Multiple doses
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Up to 47 days
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OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
기간: Up to 29 days
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OC = Oral contraceptives
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Up to 29 days
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OC part: Maximum measured concentration of the analyte in plasma (Cmax)
기간: Up to 29 days
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Up to 29 days
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2차 결과 측정
결과 측정 |
기간 |
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SD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
기간: Up to 11 days
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Up to 11 days
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SD part: Maximum measured concentration of the analyte in plasma (Cmax)
기간: Up to 11 days
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Up to 11 days
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MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
기간: Up to 39 days
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Up to 39 days
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MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
기간: Up to 39 days
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Up to 39 days
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OC part: 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)
기간: Up to 29 days
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Up to 29 days
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1516-0005
- U1111-1331-6622 (레지스트리 식별자: WHO International Clinical Trials Registry Platform (ICTRP))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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미다졸람에 대한 임상 시험
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Al Jedaani Hospital완전한
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Jiangsu Hansoh Pharmaceutical Co., Ltd.모병
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