NL-OMON53684已完成不适用
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of REC-3964 in Healthy Subjects - SAD PK study with REC-3964
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
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. Subject is male or female aged >= 18 to <= 65 years. For Cohort A6 and
- •potentially for Cohort B5, subject is male or female aged > 65 years (note:
- •there is no upper limit for the subject*s age).
- •2. Subject must provide written informed consent prior to initiation of any
- •study procedures.
- •3. Subject*s body mass index is between 18 and 32 kg/m2, inclusive, with a
- •minimum body weight of 50 kg.
- •4. Subject is healthy as determined by medical history, physical examination,
- •vital signs, and 12 lead ECG. For any abnormalities, the subject may be
- •included only if the Investigator judges the abnormalities or deviations from
- •normal to be not clinically significant.
- •5. Subject*s clinical laboratory test results (hematology including
- •reticulocyte count, biochemistry, coagulation, urinalysis, comprehensive
- •metabolic panel, and complete blood count) are clinically acceptable as
- •determined by the Investigator at Screening and Admission.
排除标准
- •1. Subject has any clinically significant laboratory abnormality or illness
- •which, in the opinion of the Investigator, could interfere with the conduct or
- •interpretation of the study or put the subject at risk.
- •2. Subject has any condition that, in the opinion of the Investigator, could
- •affect drug absorption (eg, stomach or intestinal surgery such as
- •cholecystectomy or bariatric surgery, gastroesophageal reflux disease,
- •irritable bowel syndrome, or celiac disease).
- •3. Subject has a known history of hypersensitivity to the drug class or its
- •excipients.
- •4. Subject has a history of alcohol or substance abuse within 1 year prior to
- •screening for study participation, or is currently using alcohol, drugs of
- •abuse, or any prescribed or over-the-counter medication in a manner, which, in
- •the opinion of the Investigator, indicates abuse.
- •5. Subject has been treated with prescription, over-the-counter, dietary, or
- •herbal supplements that are CYP3A inhibitors or inducers within 14 days before
- •the first dose of study drug: eg, ketoconazole, itraconazole, voriconazole,
- •posaconazole, clarithromycin, telithromycin, nefazodone, rifampin, rifapentine,
- •rifabutin, grapefruit juice, Valencia oranges, or St. John*s Wort.
研究者
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