An Open Label, Phase 1 Study to Assess the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499
研究概览
简要总结
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are 18 to 55 years of age.
- •Participants who are overtly healthy.
- •One SARs-CoV-2 negative test is required prior to dosing
- •Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive).
- •Capable of giving signed informed consent.
- •Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
排除标准
- •History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- •Current or chronic liver disease, hepatic or biliary abnormalities, or relevant hepatitis.
- •Abnormal blood pressure.
- •Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years. Participants with exclusionary electrocardiogram findings.Positive HIV test or ongoing behaviors that put the participant at high risk for HIV acquisition.
- •Participants who are breastfeeding or plan to become pregnant during the study.
- •Past or intended use of exclusionary medications or vaccines.
- •Exposure to >4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
- •ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimated serum creatinine clearance <60 mL/min.
- •History of or current infection with hepatitis B or hepatitis C.
- •Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
- •Positive HIV antibody test.
- •Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.
研究组 & 干预措施
Part 1 Dose A - Fasted condition
VH4011499 Dose A tablet administered in fasted condition.
干预措施: VH4011499 Dose A (Drug)
Part 1 Dose A- Fed condition (high fat meal)
VH4011499 Dose A tablet administered in fed condition (high fat meal).
干预措施: VH4011499 Dose A (Drug)
Part 2 Dose B - Optional - Fed condition (low fat meal)
VH4011499 Dose B tablet administered in fed condition (low fat meal).
干预措施: VH4011499 Dose B (Drug)
Part 3 Dose B - Fasted condition
VH4011499 Dose B tablet administered in fasted condition.
干预措施: VH4011499 Dose B (Drug)
Part 3 Dose B - Fed condition (high fat meal)
VH4011499 Dose B tablet administered in fed condition (high fat meal).
干预措施: VH4011499 Dose B (Drug)
结局指标
主要结局
Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499
时间窗: From Day 1 (pre-dose) to Day 28
Maximum observed plasma drug concentration (Cmax) of VH4011499
时间窗: From Day 1 (pre-dose) to Day 28
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499
时间窗: From Day 1 (pre-dose) to Day 28
Time to maximum observed plasma concentration (Tmax) of VH4011499
时间窗: From Day 1 (pre-dose) to Day 28
次要结局
- Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters(From Day 1 (pre-dose) to Day 28)
- Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)(From Day 1 (pre-dose) to Day 28)
- Number of participants with AEs (Adverse Events), by severity(From Day 1 (pre-dose) to Day 28)
- Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)(From Day 1 (pre-dose) to Day 28)