ISRCTN14438276进行中（未招募）1 期
A two-part, open-label, randomised, cross-over study to compare new tablet formulations of RO7486967 to the capsule formulation, to perform a preliminary dose proportionality assessment and to estimate the effect of food on the pharmacokinetics of the tablet formulations in healthy participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
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
- •2. Aged 18 to 55 years inclusive at the time of signing the informed consent
- •3. Body mass index (BMI) of 18.0 to 30.0 kg/m², inclusive, as measured at screening
- •4. Participants must be willing and able to communicate and participate in the whole study and comply with study requirements
- •5. Participants must provide written informed consent
- •6. Participants must agree to adhere to the contraception requirements defined in the clinical protocol
排除标准
- •1. Participants who have received any IMP in a clinical research study within the 90 days prior to the planned first dose date of this study (i.e., Day 1 of Period 1), or less than 5 elimination half-lives prior to Day 1 of Period 1, whichever is longer. Participants who are enrolled and dosed in Part 1 are permitted to be enrolled in Part 2, only if there is a minimum of 90 days washout between the final dose of RO7486967 in Part 1 and the first dose of RO7486967 in Part 2.
- •2. Participants who are, or are immediate family members of, a study site or sponsor employee.
- •3. Positive test for SARS-CoV-2 within 30 days prior to Day 1 of Period 1 or evidence of recent SARS-CoV-2 symptomatic infection within the last 3 months. Participants who had asymptomatic, incidental, positive findings can be included if tested more than 30 days prior to screening and test negative at screening and prior to admission to the clinical unit.
- •4. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
- •5. History of any drug or alcohol abuse in the past 2 years.
- •6. 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)
- •7. A confirmed positive alcohol breath test at screening or admission.
- •8. 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.
- •9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- •10. Females who are pregnant or lactating (all female participants must have a negative highly sensitive serum [screening] and urine [admission] pregnancy test). 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). Female subjects who are currently receiving HRT and have a serum FSH concentration <40 IU/l may be enrolled at the discretion of the investigator.
- •11. Male participants with pregnant or lactating partners
- •12. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •13. Clinically significant abnormal clinical chemistry, haematology, coagulation (screening only) or urinalysis as judged by the investigator. Note: Participants with Gilbert’s Syndrome are not allowed.
- •14. ALP, AST, ALT, total bilirubin or GGT >ULN, INR >1.5 or albumin <34 g/l at screening. Repeat testing (one repeat test at screening and one repeat test at admission) is acceptable for out of range values following approval by the investigator or delegate.
- •15. Confirmed positive drugs of abuse test result.
- •16. Positive QuantiFERON test at the screening visit or within 2 months prior to screening.
- •17. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- •18. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <70 mL/min using the Cockcroft-Gault equation
- •19. Abnormal ECG findings at screening and pre-dose that are considered by the investigator to be cl
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