NL-OMON46088已完成不适用
A single-center, non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of Rifampicin on the pharmacokinetics of multiple doses of Balovaptan in healthy volunteers - Balovaptan - Rifampicin DDI study
PRA Health F. Hoffmann-La Roche Ltd0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
- •1. Healthy male and female subjects, aged 18-65, inclusive at screening.
- •2. BMI of 18-30Kg/m2, inclusive at screening
- •3. Women of childbearing potential must agree to use one highly effective non-hormonal contraceptive method combined with a barrier method from screening until 90 days after the last drug dose.
- •4. Men must agree to use contraceptive measures and refrain from donating sperm.
- •5. Able to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •1. Female subjects who are pregnant or lactating.
- •2. If female of childbearing potential, a positive serum pregnancy test at Screening or at admission (Day 1 of either period).
- •3. 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.
- •4. 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.
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