Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Bayer Clinical Trials Contact
- 电话号码:(+)1-888-84 22937
- 邮箱:clinical-trials-contact@bayer.com
学习地点
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Quebec
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Mount Royal、Quebec、加拿大、H3P 3P1
- 招聘中
- Altasciences
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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实验性的: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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
大体时间: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)
大体时间: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)
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
大体时间: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))
大体时间: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)
大体时间: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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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 22791
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IPD 计划说明
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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