NL-OMON51781已完成不适用
An open-label, mass balance study of 14C-JNJ-40411813 administered as a single oral dose in healthy male participants - Mass balance study of 14C-JNJ-40411813 in healthy male participants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
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. Age: 18 (or the legal age of consent in the jurisdiction in which the study
- •is taking place) to 55 years of age, inclusive.
- •2. Healthy on the basis of physical examination, medical history, vital signs,
- •and 12-lead ECG performed at screening. If there are any abnormalities, they
- •must be considered not clinically relevant, and this determination must be
- •recorded in the participant's source documents and initialed by the
- •investigator.
- •3. Healthy on the basis of clinical laboratory tests performed at screening. If
- •the results of the serum chemistry panel, hematology, coagulation, or
- •urinalysis are outside the normal reference ranges, the participant may be
- •included only if the investigator judges the abnormalities or deviations from
- •normal to be not clinically significant or to be appropriate and reasonable for
- •the population under study. This determination must be recorded in the
- •participant's source documents and initialed by the investigator.
- •4. Blood pressure (after the participant is supine for 5 minutes) between 90
- •mm and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic at
- •screening. If blood pressure is out of range, up to 2 repeated assessments are
- •5. Must not have current COVID-19 infection, confirmed by SARS-CoV-2 polymerase
- •chain reaction (PCR), on Day -1.
- •6. Weight : Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body
- •weight not less than 50.0 kg.
- •Further criteria apply
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 (including any abnormal bleeding or blood
- •dyscrasias), lipid abnormalities, significant pulmonary disease, including
- •bronchospastic respiratory* disease, diabetes mellitus, hepatic
- •insufficiency, impaired hepatobiliary function (gall bladder removed, has a
- •hepatobiliary shunt, etc), thyroid disease, neurologic or psychiatric
- •disease**, infection, or any other illness that the investigator considers
- •should exclude the participant or that could interfere with the interpretation
- •of the study results.
- •*Participants with childhood asthma that resolved by the age of 12 years are
- •**Participants with a history of a suicidal attempt at any time in the past, or
- •suicidal ideation within the past year, as measured by the Columbia-Suicide
- •Severity Rating Scale (C-SSRS) baseline/screening version are excluded.
- •2. Participant has ALT or aspartate aminotransferase values >=1.5x the upper
- •limit of normal (ULN) or total bilirubin >1.5 times the ULN at screening.
- •3. Creatinine clearance <=61 mL/min based on Chronic Kidney Disease
- •Epidemiology Collaboration formula at screening.
- •4. History of malignancy within 5 years before screening (exceptions are
- •squamous and basal cell carcinomas of the skin and carcinoma in situ of the
- •cervix, or malignancy, which is considered cured with minimal risk of
- •recurrence).
- •5. History of stomach or intestinal surgery or resection, including
- •cholecystectomy, that would potentially alter absorption or excretion of orally
- •administered drug (appendectomy and hernia repair will be allowed).
- •Further criteria apply
研究者
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