EUCTR2017-003956-22-Outside-EU/EEA进行中（未招募）1 期
A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Oral Granule Formulation of Ledipasvir/Sofosbuvir in Healthy Adult Subjects
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •1. Have the ability to understand and sign a written informed consent form (ICF),
- •2. Be between 18 and 45 years of age, inclusive
- •3. Must have a calculated BMI between =19.0 to =30.0 kg/m2 at Screening
- •4. Creatinine clearance (CLCr) must be =90 mL/min
- •5. Females of childbearing potential (as defined in Appendix 3) must have a negative serum pregnancy test at Screening and Day -1
- •6. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods (as defined in Appendix 3) from 3 weeks prior to clinic admission until 30 days following the last dose of study drug
- •7. Male subjects must agree to utilize a highly effective method of contraception (as defined in Appendix 3) during heterosexual intercourse from clinic admission until 90 days following the last dose of study drug.
- •8. Male subjects must agree to refrain from sperm donation from Day -1 until at least 90 days after the study drug dose
- •9. Subjects must have refrained from blood donation within 56 days or plasma donation within 7 days of study dosing and from clinic admission until 30 days following the last dose of study drug
- •10. In the opinion of the investigator, subjects must be in good health based upon medical history and physical examination (including vital signs)
- •11. Screening laboratory evaluations without clinically significant abnormalities as assessed by the investigator
- •12. Be willing and able to comply with all study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •1. Alcohol or substance abuse as assessed by the investigator
- •2. A positive screening test result for human immunodeficiency virus type 1 (HIV-1) antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody
- •3. Nursing female
- •4. Have previously been participated in an investigational trial involving administration of any investigational compound (last dose) within 30 days prior to the study dosing (Day 1)
- •5. Have poor venous access limiting phlebotomy
- •6. Have been vaccinated within 90 days, or for the influenza vaccine, within 14 days prior to study dosing
- •7. Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications
- •8. Have taken systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study
- •9. Have a history of any of the following:
- •a. Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
- •b. Significant serious skin disease, such as but not limited to, rash or eruptions, food allergy, eczema, psoriasis, or urticaria
- •c. Known hypersensitivity to the study drugs, the metabolites or to formulation excipients (see Section 5.2.1)
- •d. Syncope, palpitations, or unexplained dizziness
- •e. Liver disease or liver function tests such as alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum total bilirubin, or alkaline phosphatase above the upper limit of normal at Screening
- •f. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment
- •g. Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery)
- •h. Significant cardiac disease (including history of myocardial infarction based on electrocardiogram [ECG] and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40%) or a family history of Long QT Syndrome
- •10. The following ECG abnormalities at Screening: QRS > 120 msec; heart rate < 45 beats per minute; second or third degree heart block, QTcF interval > 450 msec for males or > 470 msec for females; PR interval > 200 msec and any other clinically relevant abnormality
- •11. Believed, by the study investigator, to be inappropriate for study participation for any reasond. Syncope, palpitations, or unexplained dizziness
- •e. Liver disease or liver function tests such as alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum total bilirubin, or alkaline phosphatase above the upper limit of normal at Screening
- •f. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment
- •g. Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery)
- •h. Significant cardiac disease (including history of myocardial
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