Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
2026년 8월 8일 업데이트: Bayer
A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
100
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Bayer Clinical Trials Contact
- 전화번호: (+)1-888-84 22937
- 이메일: clinical-trials-contact@bayer.com
연구 장소
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Quebec
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Mount Royal, Quebec, 캐나다, H3P 3P1
- 모병
- Altasciences
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent.
- Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.
- Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.
- Signed informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
- Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).
- Known or suspected hypersensitivity to the study intervention(s) or their excipients.
- Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).
- Febrile illness within 2 weeks prior to first administration of study intervention.
- History of clinically relevant seizures or endometrial tumors.
- Use of moderate or strong CYP3A4 inhibitors or inducers within 4 weeks prior to first study intervention.
- Participation in another clinical study within 30 days prior to first study intervention or concurrent participation in another trial.
- Clinically relevant abnormal laboratory findings at screening, including elevated liver enzymes or positive virology tests.
- Positive pregnancy test at screening or prior to dosing, or breastfeeding. Positive drug abuse or alcohol test at screening.
- Smoking more than 10 cigarettes per day within 3 months prior to screening.
- Special diets incompatible with study requirements or inability to comply with study procedures.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Sequence 1: Treatment A followed by Treatment B
Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods.
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Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
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실험적: Sequence 2: Treatment B followed by Treatment A
Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods.
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Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
기간: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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elinzanetant administered in the evening 3 hours after a light dinner.
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On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md)
기간: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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elinzanetant administered in the evening 3 hours after a light dinner.
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On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
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Minimum Observed Plasma Concentration During Dosing Interval After Multiple Dosing (Cmin,md)
기간: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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elinzanetant administered in the evening 3 hours after a light dinner.
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On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
기간: From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
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From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
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Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))
기간: On Day 2 of each 12-day treatment period
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elinzanetant administered in the evening under fasted conditions.
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On Day 2 of each 12-day treatment period
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Maximum Observed Plasma Concentration After Single Dose (Cmax)
기간: On Day 2 of each 12-day treatment period
|
elinzanetant administered in the evening under fasted conditions.
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On Day 2 of each 12-day treatment period
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 22일
기본 완료 (추정된)
2027년 2월 22일
연구 완료 (추정된)
2027년 2월 22일
연구 등록 날짜
최초 제출
2026년 7월 15일
QC 기준을 충족하는 최초 제출
2026년 8월 8일
처음 게시됨 (실제)
2026년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 8일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 22791
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing".
This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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