NL-OMON50454已完成不适用
An open-label, non-randomized, fixed-sequence crossover study to investigate the effects of the proton pump inhibitor esomeprazole on the pharmacokinetics of elinzanetant (BAY 3427080) as well as assessment of the absolute bioavailability of elinzanetant using a single intravenous microtracer dose of [13C5]BAY 3427080 in male and female healthy participants. - Esomeprazole interaction and AB study for elinzanetant (BAY 3427080)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Participant must be 18 to 65 years of age inclusive, at the time of signing
- •the informed consent.
- •2. Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, laboratory tests, and cardiac
- •monitoring.
- •3. Body weight of at least 50 kg and body mass index (BMI) within the range of
- •18.0 to 30.0 kg/m^2 (inclusive).
- •4. Male and female
- •Contraceptive use by men or women should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •- Male participants: Male participants of reproductive potential must agree to
- •use a condom (with or without spermicide) when sexually active. This applies
- •for the time period between the signing of the
- •informed consent form (ICF) until 5 days after the last dose of study
- •intervention. Female partners of childbearing potential of male participants do
- •not need to follow special precautions.
- •- Female participants: Women of childbearing potential will have to use highly
- •effective non-hormonal contraception when having sexual intercourse with a male
- •partner from signing the ICF until 5 days after last dose of the study drug.
- •-- Women of non-childbearing potential are not required to use contraception.
- •Non-childbearing potential is defined as
- •- Postmenopausal state confirmed by follicle stimulating hormone (FSH) level
- •>33.4 U/L, or above reference range from the local laboratory, or
- •- Surgically sterilized by bilateral tubal ligation, bilateral oophorectomy
- •with or without hysterectomy, or hysterectomy documented by medical report
- •verification.
排除标准
- •1. Any clinically relevant abnormal findings in medical history and physical
- •examination which in the opinion of the investigators, may put the participant
- •at risk because of his/her participation in the trial or provide difficulties
- •in interpreting the trial data.
- •2. History or evidence of any clinically relevant cardiovascular,
- •gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic,
- •urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other
- •clinically relevant disease, as judged by the investigator.
- •3. Pre-existing diseases for which it can be assumed that the absorption,
- •distribution, metabolism, elimination and effects of the study intervention
- •will not be normal.
- •4. Any medical disorder, condition or history of such that would impair the
- •participant's ability to participate or complete this study in the opinion of
- •the investigator.
- •5. Known hypersensitivity to the study interventions (active substances, or
- •excipients of the preparations).
- •6. Known severe allergies e.g., allergies to more than 3 allergens, allergies
- •affecting the lower respiratory tract - allergic asthma, allergies requiring
- •therapy with corticosteroids, urticaria or significant nonallergic drug
- •7. Relevant diseases within the last 4 weeks prior to the first study
- •intervention administration.
- •8. Febrile illness within 4 weeks before first study intervention
- •administration.
- •9. Contraindications for the use of esomeprazole, especially known hereditary
- •problems of fructose intolerance, glucose-galactose malabsorption or
- •sucrase-isomaltase insufficiency
- •10. Use of drugs which may affect absorption (e.g. loperamide, metoclopramide)
- •within 1 week before first study drug administration.
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