NL-OMON52038已完成不适用
A three-part, phase 1, randomized, controlled, dose-escalation study of INT-787 following single or multiple dose administration in healthy subjects. - SAD/MAD/FE Dose-Escalation Study of INT-787 in healthy subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
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. Subject must be male (18 to 55 years of age, inclusive) or female (gender
- •effect cohort only; 18 to 55 years of age, inclusive).
- •2. Female subjects (included in the gender effect cohort only) must be of
- •non-childbearing potential, who have undergone a sterilization procedure at
- •least 6 months prior to dosing with official documentation (e.g., hysteroscopic
- •sterilization, bilateral tubal ligation or bilateral salpingectomy,
- •hysterectomy, or bilateral
- •oophorectomy), or are postmenopausal with amenorrhea for at least 1 year prior
- •to dosing and folliclestimulating hormone (FSH) serum levels consistent with
- •postmenopausal status and serum pregnancy test at screening and upon admission
- •with a negative result as per Investigator*s judgment.
- •3.Male subjects who are sexually active with a woman of childbearing potential
- •and have not had a vasectomy must agree to use a barrier method of birth
- •control (e.g., either condom or partner with occlusive cap [diaphragm or
- •cervical/vault caps]). Male subjects must also agree to not donate sperm for
- •the duration
- •of the study and for at least 90 days after study discharge.
- •4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
- •5. Judged to be in good health on the basis of medical history, physical
- •examination, and routine laboratory measurements (i.e., without clinically
- •relevant pathology).
排除标准
- •1.History of any illness or condition that, in the opinion of the Investigator,
- •might confound the results of the study or pose an additional risk in
- •administering investigational product to the subjects.
- •2. Smokers (subjects who have smoked within 3 months of screening or those with
- •positive results from the cotinine urine test).
- •3. Inflammatory bowel disease, cholecystectomy or surgery of the
- •gastrointestinal tract that could interfere with pharmacokinetics of the study
- •medication (except appendectomy and simple hernia repair).
- •4. Routine treatment with prescription medications. Subjects should have
- •stopped taking any prescription and nonprescription medications at least 14
- •days before the first dosing of investigational product. Potential subjects
- •should only stop taking any prescription and nonprescription medications at the
- •direction of a
- •5. Consumption of herbal medications, dietary supplements, and specific fruit
- •products. Subjects should have stopped consumption of herbal medications or
- •dietary supplements (e.g., St. John*s Wort, ginkgo biloba, and garlic
- •supplements), vitamins, grapefruit, grapefruit hybrids or grapefruit juice,
- •Seville oranges,
- •pomelos, cranberries, pomegranates, star fruit, apples, vegetables from the
- •mustard green family (e.g., kale, broccoli, watercress, collard greens,
- •Brussels sprouts, and mustard) and charbroiled meats for 7 days prior to Day 1,
- •on any dosing day, and through the completion of the last PK sampling.1.
研究者
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