NL-OMON50152已完成不适用
A phase 1, open-label, randomized, 2-way crossover study to assess the effects of acid reducing agent(s) on the pharmacokinetics of a single oral dose of JNJ-64417184 in healthy adult participants - Drug-drug Interaction of Multiple-dose JNJ-64417184
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
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, 18 to 54 years of age, extremes included, at screening.
- •2. Must have a body mass index between 18.0 and 30.0 kg/m2, extremes included,
- •and body weight not less than 50.0 kg at screening.
- •3. Healthy on the basis of physical examination, medical and surgical history,
- •and vital signs performed at screening. If there are abnormalities other than
- •those listed in Exclusion Criteria 2 and 3, the participant may be included
- •only if the investigator judges the abnormalities 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. Must have a normal 12-lead ECG (triplicate) at screening, including: normal
- •sinus rhythm (heart rate between 45 and 100 beats per minute, extremes
- •included); QT interval corrected for heart rate (QTc) according to Fridericia
- •(QTcF) <=450 ms for male participants and <=470 ms for female participants; QRS
- •interval <120 ms; PR interval <=200 ms. If the results of the ECG are outside
- •the normal ranges, the participant may be included only if the investigator
- •judges the deviations from normal ECG 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.
- •5. Must not use nicotine-containing substances including tobacco products (eg,
- •cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least
- •3 months prior to screening.
- •For additional inclusion criteria, cross-refer to the protocol
排除标准
- •1. History of liver or renal dysfunction (calculated creatinine
- •clearance/estimated glomerular filtration rate (eGFR) <60 mL/min at screening,
- •calculated by the Modification of Diet in Renal Disease [MDRD] formula),
- •significant cardiac, vascular, pulmonary, gastrointestinal (such as significant
- •diarrhea, gastric stasis, or constipation that in the investigator*s opinion
- •could influence drug absorption or bioavailability), endocrine, neurologic,
- •hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
- •2. Past history of clinically significant cardiac arrhythmias (eg,
- •extrasystoli, tachycardia at rest), history of risk factors for Torsade de
- •Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome).
- •3. Any evidence of clinically significant heart block or bundle branch block at
- •4. Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection
- •(confirmed by antibodies) at screening.
- •5. History of hepatitis A, B, or C infection, or current hepatitis A infection
- •(confirmed by hepatitis A antibody immunoglobulin M [IgM]), or HBV infection
- •(confirmed by hepatitis B surface antigen), or HCV infection (confirmed by HCV
- •antibody) at screening.
- •For additional exclusion criteria cross-refer to the protocol
研究者
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