NL-OMON51387已完成不适用
A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens - JNJ-64281802 Multiple Dose Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
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. 18 to 55 years of age, extremes included, at the time of screening.
- •2. Healthy on the basis of physical examination, medical history (at screening
- •only), and vital signs performed at screening and Day -1. If
- •there are abnormalities, 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.
- •3. Healthy on the basis of clinical laboratory tests performed at screening and
- •Day -1. If the results of the serum chemistry panel, blood
- •coagulation, hematology, or urinalysis are outside the normal reference ranges
- •(except for those listed in the exclusion criteria), the
- •participantmay 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.
- •4. Body weight not less than 50 kg and body mass index (BMI; weight kg/height^2
- •m^2) within the range 18.0 and 30.0 kg/m^2, extremes
- •included, at screening and Day -1.
- •5. Man or woman
排除标准
- •1. History of or current clinically significant medical illness including (but
- •not limited to) cardiac arrhythmias (eg, extrasystole, tachycardia at rest) or
- •other cardiac disease, risk factors for Torsade de Pointes syndrome (eg,
- •hypokalemia, family history of long QT Syndrome), 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 (creatinine clearance below 60 mL/min at
- •screening, calculated by the Modification of Diet in Renal Disease [MDRD]
- •formula, vascular, gastrointestinal (such as significant diarrhea, gastric
- •stasis, or constipation that in the investigator's opinion could influence drug
- •absorption or bioavailability), rheumatologic, neoplastic, endocrine, thyroid
- •disease, neurologic or psychiatric disease, infection, metabolic disturbances,
- •or any other illness that the investigator
- •considers should exclude the participant or that could interfere with the
- •interpretation of the study results.
- •2. Participants with one or more of the following laboratory abnormalities at
- •screening, as defined by the World Health Organization (WHO) Toxicity Grading
- •Scale and in accordance with the normal ranges of the clinical laboratory if no
- •gradings are available:
- •- Serum creatinine elevation Grade 1 or greater (>=1.1×upper limit of normal
- •- Hemoglobin lowering Grade 1 or greater (<=10.5 g/dL)
- •- Platelets count lowering Grade 1 or greater (<=99,000/mm³)
- •- Absolute neutrophil count lowering Grade 1 or greater (<=1,500/mm³)
- •- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation
- •Grade 1 or greater (>=1.25 ×ULN)
- •- Total bilirubin Grade 1 or greater (>=1.1 ×ULN)
- •- Any other laboratory toxicity Grade 2 or greater (for elevations of
- •triglycerides, low-density lipoprotein (LDL) cholesterol, and/or total
- •cholesterol: Grade 3 or greater).
- •3. Any history of clinically significant skin disease such as, but not limited
- •to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria.
- •4. Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its
- •excipients.
- •5. Has been dosed with JNJ-64281802 in past 3 months.
研究者
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