NL-OMON51381已完成不适用
A single-center, two-part, randomized, open-label, parallel-group, four-sequence, four-treatment, four-period crossover study to investigate the bioequivalence and the effect of food on the pharmacokinetics and safety of single oral doses of two different formulations of RO6868847 in healthy participants - A bioequivalence and food effect study of two RO6868847 tablet formulations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
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. Willing to participate and able to give written informed consent and to
- •comply with the study restrictions according to International Council for
- •Harmonisation (ICH) and local regulations.
- •2. Male or female, between 18 to 64 years of age, inclusive, at screening.
- •3. Healthy participants. Health status is defined by absence of evidence of any
- •active or chronic disease following a detailed medical and surgical history, a
- •complete physical examination including vital signs, 12-lead ECG, hematology,
- •blood chemistry, serology, coagulation, and urinalysis.
- •4. Participants must weigh at least 50.0 kg and must have a body mass index
- •(BMI) within the range of 18.0 to 32.0 kg/m2, inclusive.
- •5. Male and female: The contraception and abstinence requirements are intended
- •to prevent exposure of an embryo to the study treatment. The reliability of
- •sexual abstinence for enrollment eligibility needs to be evaluated in relation
- •to the duration of the clinical study and the preferred and usual lifestyle of
- •the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
- •or post-ovulation methods) and withdrawal are not acceptable methods of
- •preventing fetal/embryonic drug exposure.
- •A female participant is eligible to participate if she is not pregnant, not
- •breastfeeding, and at least one of the following conditions applies:
- •Woman of non-childbearing potential (WONCBP).
- •Woman of childbearing potential (WOCBP), who:
- •- Agrees to remain abstinent (refrain from heterosexual intercourse) or use a
- •condom plus an additional highly effective contraceptive method that results in
- •a failure rate of <1% per year during the treatment period and for at least 90
- •days after the last dose of study treatment. Examples of contraceptive methods
- •with a failure rate of <1% per year include bilateral tubal occlusion,
- •intercourse with a sterilized male, established proper use of hormonal
- •contraceptives that inhibit ovulation, hormone-releasing intrauterine devices,
- •and copper intrauterine devices.
- •- Has a negative pregnancy test at screening and Day -1.
- •During the treatment period and for at least 90 days after the last dose of
- •study treatment, agree to:
- •Remain abstinent (refrain from heterosexual intercourse) or use a condom plus
- •an additional highly effective contraceptive method that results in a failure
- •rate of <1% per year as described above, with a partner who is a WOCBP.
- •With pregnant female partner, remain abstinent (refrain from heterosexual
- •intercourse) or use contraceptive measures such as a condom to avoid exposing
- •the embryo.
- •Refrain from donating sperm.
排除标准
- •1. History of any clinically significant gastrointestinal, renal, hepatic,
- •broncho pulmonary, neurological, psychiatric, cardiovascular, endocrinological,
- •hematological or allergic disease, metabolic disorder, or cirrhosis.
- •2. Concomitant disease or condition that could interfere with, or treatment of
- •which might interfere with, the conduct of the study, or that would, in the
- •opinion of the Investigator, pose an unacceptable risk to the participant in
- •this study including, but not limited to, any major illness within 4 weeks
- •before the screening examination or any febrile illness within 1 week prior to
- •screening and up to first study treatment administration.
- •3. History or evidence of any medical condition potentially altering the
- •absorption, metabolism, or elimination of drugs. Surgical history of the
- •gastrointestinal tract affecting gastric motility or altering the
- •gastrointestinal tract (with the exception of uncomplicated appendectomy and
- •hernia repair).
- •4. History or presence of clinically significant ECG abnormalities based on the
- •average of triplicate ECG recordings (e.g., PQ/PR interval >210 ms, QTcF >450
- •ms for males and QTcF >470 ms for females) or cardiovascular disease (e.g.,
- •cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive
- •heart failure, family history of congenital long QT syndrome, family history of
- •sudden death).
- •5. History of malignancy in the past 5 years.
- •Further criteria apply
研究者
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