NL-OMON48293已完成不适用
A Phase 1, Open-label, Randomized, 3-way Crossover Study to Assess the Pharmacokinetic Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Subjects - DDI study JNJ-64417184 and JNJ-53718678
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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. Male or female, between 18 and 55 years of age, extremes included, at
- •2. Body mass index (BMI; weight [kg]/height2 [m]2) between 18.0 and 30.0 kg/m2,
- •extremes included, and body weight not less than 50 kg at screening.
- •3. Healthy on the basis of physical examination (including skin examination),
- •medical and surgical history, and vital signs (systolic blood pressure [SBP],
- •diastolic blood pressure [DBP], and pulse rate [after the subject is supine for
- •at least 5 minutes], respiratory rate, and oral body temperature) performed at
- •screening. If there are abnormalities (not applicable for the parameters listed
- •in inclusion criterion 5 [for blood pressure]), the subject may be included
- •only if the investigator judges the abnormalities to be not clinically
- •significant. This determination must be recorded in the subject's source
- •documents and initialed by the investigator.
- •4. Healthy on the basis of clinical laboratory tests performed at screening. If
- •the results of the hematology, biochemistry, blood coagulation, or urinalysis
- •are outside the normal reference ranges (not applicable for the parameters
- •listed in exclusion criteria 1 and 2 [for laboratory parameters]), the subject
- •may be included only if the investigator judges the abnormalities or deviations
- •from normal to be not clinically significant. This determination must be
- •recorded in the subject's source documents and initialed by the investigator.
- •5. Blood pressure (after the subject is supine for 5 minutes) between 90 and
- •140 mmHg systolic, extremes included, and no higher than 90 mmHg diastolic at
- •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 or renal
- •insufficiency (calculated creatinine clearance/estimated glomerular filtration
- •rate [eGFR] <60 mL/min at screening, calculated by the Modification of Diet in
- •Renal Disease [MDRD] formula30), thyroid disease, neurologic or psychiatric
- •disease, infection, or any other illness that the investigator considers should
- •exclude the subject or that could interfere with the interpretation of the
- •study results.
- •2. Any laboratory abnormality >=grade 1 (as defined by the Division of Acquired
- •Immune Deficiency Syndrome [DAIDS] Table for Grading the Severity of Adult and
- •Pediatric Adverse Events)9, considered to be clinically significant by the
- •investigator at screening.
- •3. Past history of cardiac arrhythmias (eg, extrasystoli, tachycardia at rest),
- •history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia,
- •family history of long QT Syndrome).
- •4. Any evidence of heart block or bundle branch block at screening.
- •5. History of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection,
- •or tests positive for HIV-1 or -2 at screening.
研究者
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