NL-OMON30846已完成不适用
A Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Oral Dose Study to Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of JNJ-26070109 In Healthy Subjects - MAD (Multiple Ascending Dose) study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
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
- •Female subjects must not be of childbearing potential, ie must be surgically sterile (> 6 months) or post-menopausal (no menses for > 2 years).
- •Subjects must have supine blood pressure (after resting for 5 min) between the range of 95 - 139 mm Hg systolic (inclusive), and 50 - 89 mm Hg diastolic (inclusive).
- •Subjects must be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, blood chemistry, complete blood count (CBC), UA, and ECG.
- •Male subjects must consent to utilize a medically acceptable method of contraception throughout the entire study period and for 3 months after the study is completed.
- •Subjects must be Helicobacter pylori negative at screening.
排除标准
- •Subjects with evidence of clinically significant hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, respiratory, endocrine/metabolic, or cardiovascular system abnormalities, psychiatric disorders, oncologic conditions or acute or chronic infection.
- •Subjects with past or current gastric or duodenal ulceration.
- •Subjects with history of lactose intolerance.
- •Subjects who have a history of having a first degree relative die from cardiac causes prior to the age of 40 years.
- •Subjects with significant history of heartburn or other symptoms of gastroesophageal reflux disease (GERD) or subjects who have used prescription, or non-prescription medications, for symptoms of heartburn or symptoms of GERD within 3 months prior to screening.
- •Subjects who have taken JNJ-26070109 previously in a clinical study.
研究者
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