EUCTR2021-000436-62-Outside-EU/EEA进行中（未招募）1 期
A Phase 1, Single-Dose, Cross-Over Study Evaluating the Relative Bioavailability and Food Effect of a Pediatric Tablet for Oral Suspension of Bictegravir/Emtricitabine/Tenofovir Alafenamide and the Bioequivalence of a Pediatric Tablet for Oral Suspension of Emtricitabine/Tenofovir Alafenamide in Healthy Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures
- •2. Be aged 18 through 45 years of age, inclusive at screening
- •3. Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug
- •4. Have a calculated body mass index (BMI) of = 19.0 and = 30.0 kg/m2 at screening
- •5. Have a creatinine clearance (CLcr) = 90 mL/min (using the Cockcroft-Gault method {Cockcroft 1976}) based on serum creatinine and actual body weight as measured at screening
- •6. Females of childbearing potential must have a negative serum pregnancy test at screening and clinic admission (unless permanently sterile or greater than 2 years postmenopausal)
- •7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
- •8. Subjects must refrain from sperm and egg donation from clinic admission (eg, Day -1), throughout the study period, and continuing for at least 7 days following the last dose of study drug.
- •9. Subjects have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and
- •Continuing for at least 30 days following the last dose of study drug.
- •10. Screening laboratory and 12-lead ECG evaluations must be without clinically significant abnormalities as assessed by the investigator
- •11. Have liver disease or liver function tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin equal to or below the upper limit of normal at screening
- •12. Must be willing and able to comply with all study requirements
- •13. Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs.
- •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 198
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Be a lactating female
- •2. Have received any study drug within 30 days prior to study dosing
- •3. Have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety
- •4. Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody
- •5. Have poor venous access that limits phlebotomy
- •6. Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications
- •7. Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the
- •study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
- •8. Have a history of any of the following:
- •a) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
- •b) Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
- •c) Known hypersensitivity to the study drugs their metabolites or to formulation excipients
- •d) Significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40%), a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
- •e) Syncope, palpitations, or unexplained dizziness
- •f) Implanted defibrillator or pacemaker
- •g) Liver disease, including Gilbert disease
- •h) Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment.
- •i) Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary.
- •9. Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
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