ISRCTN12868063已完成1 期
Single part, open-label, phase 1 study designed to evaluate the relative bioavailability of oral alectinib formulations compared with an oral reference alectinib capsule, in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
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
- 性别
- All
入选标准
- •1. Healthy males or non-pregnant, non-lactating healthy females of non-childbearing potential
- •2. Aged 18 to 55 years inclusive at the time of signing informed consent
- •3. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
- •4. Must be willing and able to communicate and participate in the whole study
- •5. Must provide written informed consent
- •6. Must agree to adhere to the contraception requirements defined in the protocol
排除标准
- •1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- •2. Subjects who are, or are immediate family members of, a study site or sponsor employee
- •3. Evidence of current SARS-CoV-2 infection. Subjects who have previously had evidence of COVID-19 infection may be permitted to continue in future treatment periods, on a case by case basis, as per the judgement of the investigator and sponsors’ medical monitor, provided the subject is asymptomatic, has recovered, a minimum of 14 days have passed since the initial diagnosis, and the subject has a negative PCR or antigen test before admission to the clinical unit.
- •4. History of any drug or alcohol abuse in the past 2 years
- •5. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- •6. A confirmed positive alcohol breath test at screening or admission
- •7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
- •8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •9. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive serum pregnancy test at screening and urine at all other time points). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration =40 IU/L).
- •10. Male subjects with pregnant or lactating partners
- •11. Clinically significant abnormal clinical chemistry, haematology or urinalysis at screening as judged by the investigator. Subjects will be excluded if they have ALT, aspartate aminotransferase or total bilirubin above the upper limit of the reference range or haemoglobin less than the lower limit of the reference range, neutrophil or lymphocyte count below the lower limit of normal or creatinine kinase 1.25 × the upper limit of the reference range without an alternative explanation (e.g. physical activity).
- •12. Confirmed positive drugs of abuse test result at screening or admission
- •13 Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- •14. Evidence of renal impairment at screening, as indicated by an eGFR of <80 ml/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula or any other evidence of renal impairment
- •15. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator or history of visual disturbances (e.g. blurred vision, vitreous floaters, visual impairment, reduced visual acuity, asthenopia, and diplopia) unless determined to be clinically not significant by agreement between the investigator and the sponsor’s medical monitor
- •16. Subjects with a history of cholecystectomy or gall stones
- •17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •18. Presence or history of clinically significant alle
研究者
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