NL-OMON49179已完成不适用
An Open-label, Randomized Study in Healthy Participants to Investigate Effects of Food (high-fat) and Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-67953964. - JNJ-67953964 FE and DDI study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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. Healthy male and female participants between 18 and 55 years of age,
- •2. Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 inclusive
- •(BMI=weight/height2)
- •3. Participant must be healthy on the basis of clinical laboratory tests
- •performed at screening (e.g. serum chemistry panel, hematology, and urinalysis)
- •4. Participant must be healthy on the basis of physical examination, medical
- •history, vital signs, and 12-lead ECG [QTcF <= 450 msec for males and <= 470 msec
- •for females] performed at screening and admission to the clinical unit. Minor
- •abnormalities in ECG, which are not considered to be of clinical significance
- •by the investigator, are acceptable.
- •5. Non-smokers (not smoked for 3 months prior to screening).
排除标准
- •1. History of or current significant medical illness including (but not limited
- •to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid
- •abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or
- •hepatic insufficiency, thyroid disease, Parkinson*s disease, infection, or any
- •other illness that the Investigator considers should exclude the participant.
- •2. History of any gastric surgery, documented gastric disease (including peptic
- •ulcer disease, gastritis, achlorhydria, upper GI bleeding, esophagitis, or any
- •GI precancerous condition), current clinically evident GI complaints including
- •functional gastrointestinal disorders (FGID).
- •3. Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus
- •(HCV) antibodies or human immunodeficiency virus (HIV) antibodies.
- •4. Participant has a history of at least mild drug or alcohol use disorder
- •according to Diagnostic and Statistical Manual of Mental Disorders (5th
- •edition) (DSM-V) criteria within 6 months before Screening or positive test
- •result(s) for alcohol, nicotine metabolites and/or drugs of abuse (opiates
- •[including methadone], cocaine, amphetamines, methamphetamines, cannabinoids,
- •barbiturates, ecstasy and benzodiazepines) at screening or admission.
- •5. 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).
研究者
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