A Single-Center, Part-Randomized, Open-Label, Single-Dose, Three-Period, Crossover Study to Investigate the Effect of Esomeprazole and The Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers

Hoffmann-La Roche1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2019年11月19日最近更新: 2021年3月16日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 16
试验地点: 1
主要终点: Maximum Plasma Concentration (Cmax) of Balovaptan

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•No evidence of any active or chronic disease
•Body mass index (BMI) between 18 and 32 kg/m2 inclusive, at screening
•For women of childbearing potential: if engaging in heterosexual activity, agreement to use at least two adequate forms of contraception during the entire study and for 90 days following the last dose of study drug
•For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm

排除标准

•Pregnancy or lactation (positive serum pregnancy test at screening or at admission)
•Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
•In the opinion of the Investigator, any major illness within 4 weeks prior to the screening examination or any febrile illness within 1 week prior to screening.
•History of any clinically significant, as determined by the investigator, gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, lymphatic, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue or allergic disease, metabolic disorder, or cancer
•Signs and symptoms potentially indicative of peripheral neuropathy
•History or evidence of any medical condition potentially altering the absorption, distribution, metabolism, or elimination of drugs
•A history of clinically significant in the opinion of the Investigator hypersensitivity
•History or presence of clinically significant ECG abnormalities before study drug administration
•Clinically significant abnormalities in laboratory test results
•History of coagulopathies, bleeding disorders, or blood dyscrasias
•Current suicidal risk, in the opinion of the Investigator
•Unexplained syncope during the 6 months prior to screening or with presyncopal and/or syncopal symptoms during orthostatic challenge testing
•Current smoker or user of tobacco or nicotine-containing products or subjects who have smoked or used tobacco or nicotine-containing products within 3 months prior to first study drug administration
•Suspicion of or presence of a clinically relevant history of or current alcohol and/or other substance abuse or addiction.
•Alcohol consumption of >14 units per week for males and females
•Positive urine alcohol test or urine drug screen at screening or Day -1 of any treatment period
•Hormone replacement therapy if postmenopausal status cannot be ascertained from medical history or FSH levels
•Clinically relevant deviation from normal in the physical examination including vital signs, as determined by the investigator
•Positive result for HIV 1, HIV 2, hepatitis C virus antibody, or hepatitis B core (HBc) antibody.
•Participation in an investigational drug or device study within 4 weeks or 5 times the elimination half-life, whichever is longer, prior to first dosing, or within 5 months prior to first administration of study drug in case of a study with a biological, as calculated from the day of Follow-up visit from the previous study
•Donation of blood or plasma or significant blood loss within 3 months prior to screening
•Dietary restrictions that would prohibit the consumption of standardized meals or the highfat, high-calorie meal planned for this study
•Use of any prohibited medications or food before study start or subjects who do not agree to refrain from consuming prohibited medications or food during the study
•Conditions requiring concomitant medication during the study (including for dental conditions).
•Any prescribed systemic or topical medication within 4 weeks (or within 5 times the elimination half-life of the medication, whichever is longer) of the first administration of study drug
•Used any nonprescribed systemic or topical medication or herbal remedies within 7 days before the first study drug administration
•Received any medications known to chronically alter drug absorption or elimination processes within 4 weeks before the first administration of study drug
•Use of any drugs or substances, including herbal treatments such as St John's wort, that are known to be substrates, inducers, or inhibitors of CYP3A4 within 4 weeks before the first administration of study drug
•Use of any drugs or substances, including herbal treatments, such as fluoxetine, fluvoxamine, aspirin, norethisterone, rifampicin, etc that are known to be substrates, inducers, or inhibitors of CYP2C19 within 4 weeks before the first administration of study drug
•Subjects under judicial supervision, guardianship, or curatorship
•Poor venous access for blood sampling
•Participants who are intolerant to sucrose
•Previous exposure to balovaptan

研究组 & 干预措施

Treatment sequence ABC

Experimental

In Period 1 participants will receive 1 tablet of balovaptan after high-fat, high-calorie meal. In Period 2, after 12 to 21 days wash-out, participants will receive 1 tablet of balovaptan after 10-hour fast. In Period 3 participants will receive esomeprazole administered once daily for 6 days and with a single oral dose of balovaptan in the fasted state 1 hour after the fifth esomeprazole dose

干预措施: Balovaptan (Drug)

Treatment sequence ABC

Experimental

干预措施: Esomeprazole (Drug)

Treatment sequence BAC

Experimental

In Period 1 participants will receive 1 tablet of balovaptan after 10-hour fast. In Period 2, after 12 to 21 days wash-out, participants will receive 1 tablet of balovaptan after high-fat, high-calorie meal. In Period 3 participants will receive esomeprazole administered once daily for 6 days and with a single oral dose of balovaptan in the fasted state 1 hour after the fifth esomeprazole dose

干预措施: Balovaptan (Drug)

Treatment sequence BAC

Experimental

干预措施: Esomeprazole (Drug)