NL-OMON43128已完成不适用
A Phase 1, single-dose, open-label, parallel group study to assess the relative bioavailability of simeprevir, odalasvir and AL-335 when administered in different fixed-dose combination formulations compared to the single agents when administered together, in healthy subjects - 64294178HPC1004 (CS0255)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
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
- •Inclusion Criteria:
- •-Participant must have a body mass index (BMI: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included, and a body weight not less than 50.0 kg.
- •-Participants must sign an ICF indicating that he or she understands the purpose of, and the procedures required for, the study and is willing to participate in the study.
- •-Participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •-Participants must be healthy on the basis of physical examination, medical history, vital signs, and 12lead ECG performed at screening. If there are abnormalities, 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.
- •-Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the biochemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included (except for those listed in the exclusion criteria) 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.
排除标准
- •Exclusion Criteria:
- •-Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 60
- •milliletter(ml)/min* 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.
- •-Participants has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocolspecified assessments.
- •-Participants with one or more of the following laboratory abnormalities at screening as defined by
- •the World Health Organization (WHO) Toxicity Grading Scale: 1) Serum creatinine grade 1 or greater (>=1.1 x ULN). 2) Pancreatic amylase or lipase grade 2 or greater (>1.5 x ULN). 3) Hemoglobin grade 1 or greater (<=10.5 g/dL). 4) Platelet count grade 1 or greater (<=99,000/mm^3). 5) Absolute neutrophil count grade 1 or greater (<=1,500/mm³). 6) Aspartate aminotransferase or ALT grade 1 or greater (>=1.25 x ULN). 7) Total bilirubin grade 1 or greater (>=1.1 x ULN), unless the subject is diagnosed with Gilbert*s disease. 8) Hypokalemia grade 2 or greater (<=2.9 mEq/L). 9) Hypocalcemia grade 2 or greater (<=7.7 mg/dL). 10) Hypomagnesemia grade 2 or greater (<=1.1 mEq/L) 11) Any other toxicity grade 2 or greater.
- •-Participant with a past history of heart arrhythmias (eg, extra systolic beats or tachycardia at rest)* risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first degree relative [ie, sibling, offspring, or biological parent]).
- •-Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria.
- •-Participant has known allergies, hypersensitivity, or intolerance to SMV, ODV, AL335 or their excipients.
- •-Participants has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV)
- •positive, or other clinically active liver disease, or tests positive for HBsAg or antiHCV at screening.
研究者
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