NL-OMON46329已完成不适用
A single-center, non-randomized, open-label, parallel group, two-treatment study investigating the absolute oral bioavailability of balovaptan after single and multiple daily oral doses of balovaptan in healthy volunteers* - Study to investigate the absolute oral bioavailability of balovaptan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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 99（—）
入选标准
- •- Healthy male or female subject, aged 18 to 65 years
- •- Body Mass Index (BMI) of 18 to 30 kg/m2
- •- For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable
- •- For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 90 days after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period
- •- Able to participate and willing to give written informed consent and to comply with the study restrictions
- •- Fluent in English or Dutch
排除标准
- •- If female of childbearing potential, a positive serum pregnancy test at screening or at admission to the clinical research unit
- •- 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 one month before the screening examination or any febrile illness within one week prior to screening and up to first study drug administration
- •- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, lymphatic, musculoskeletal, genitourinary, immunological, dermatological, connective tissue or allergic disease, metabolic disorder, or cancer
- •- Signs and symptoms potentially indicative of peripheral neuropathy
- •- A history of clinically significant hypersensitivity or allergic reactions
- •- Known personal or family history of congenital long QT syndrome or sudden death
- •- History or presence of clinically significant ECG abnormalities before study drug administration.
- •- Subjects with screening or predose baseline mean QT interval corrected using Fridericia*s formula >450 milliseconds [msec] or <300 msec
- •- Notable resting bradycardia on screening or predose baseline ECG. Notable resting tachycardia on screening (mean heart rate [HR] > 90 bpm) or predose (mean HR > 100 bpm) baseline ECG
- •- Screening or baseline ECGs with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement and with evidence of clinically relevant abnormalities
- •- Systolic blood pressure greater than 139 or less than 90 mmHg, or diastolic blood pressure greater than 89 or less than 45 mmHg, based on the average of >= 3 consecutive measurements.
- •- Clinically significant abnormalities in laboratory test results. In the case of uncertain or questionable results, tests performed during screening may be repeated on Day -1 of Period 1 to confirm eligibility
- •- History of coagulopathies, bleeding disorders, or blood dyscrasias
- •- Subjects who have smoked within 3 months prior to first dose administration
- •- Any clinically relevant history or any suspicion of alcohol and/or other substance abuse or addiction. Past alcohol and/or other substance abuse or addiction is also not allowed
- •- Alcohol consumption of >24 units per week for males and females
- •- Positive urine alcohol test or urine drug screen at screening or each admission
- •- Positive result on human immunodeficiency virus (HIV)-1, HIV-2 antibodies, hepatitis C virus antibody, hepatitis B virus surface antigen, or hepatitis B core antibody screen
- •- Participation in an investigational drug or device study within 90 days prior to first dosing, or within 5 months prior to first dosing in case of a study with a biological, as calculated from the day of follow-up from the previous study
- •- Any 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
- •- Use of any prohibited medications or food before study start or subjects who do not agree to refrain from consuming prohibited medications or food durin
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