NL-OMON51737已完成不适用
A Phase 1, Open Label Study to Characterize the Absorption, Metabolism, and Excretion of 14C JNJ 67953964 After a Single Dose in Healthy Adult Male Participants - JNJ-67953964 ADME study including duodenal sampling
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
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
- •-18 to 55 years of age, inclusive.
- •-Healthy on the basis of physical examination, medical history (screening
- •only), vital signs, and ECG performed at screening and admission to the study
- •site on Day -1.
- •-Healthy on the basis of clinical laboratory tests performed at screening and
- •at admission to the study center.
- •-Body weight not less than 50 kg and body mass index (BMI; weight [kg]/height2
- •[m]2) within the range of 18.0 to 29.9 kg/m2 (inclusive).
- •-A male participant during the study and for a minimum of 1 spermatogenesis
- •cycle (defined as approximately 90 days) after receiving the last dose of study
- •intervention.
排除标准
- •1. History of or current clinically significant medical illness including (but
- •not limited to) cardiac arrhythmias or other cardiac disease, hematologic
- •disease, coagulation disorders , lipid abnormalities, significant pulmonary
- •disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease,
- •neurologic or psychiatric disease, infection, or any other illness.
- •2. History of malignancy within 5 years before screening.
- •3. Known allergies, hypersensitivity, or intolerance to aticaprant or its
- •excipients.
- •4. Participant has clinically relevant GI complaints per clinical judgment at
- •screening or baseline or history of documented gastric disease.
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