NCT05844228已完成1 期
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 in Adult Participants With Renal Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
研究概览
简要总结
The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are otherwise medically stable
详细描述
Participants may be enrolled in Cohorts 1 and 2 in a non-randomized way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Additional Criteria Specific to Healthy Participants:
- •Must be in the opinion of the investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
- •Must have normal renal function as defined by eGFR ≥ 90 mL/min/1.73m^2 based on the Modification of Diet in Renal Disease (MDRD) equation determined from the mean of two measurements of serum creatinine at screening.
- •Inclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
- •Participants must, in the opinion of the investigator, be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening laboratory evaluations
- •Participants with RI must have chronic moderate or severe RI and be clinically stable per investigator assessment for at least 3 months prior to screening
- •Moderate RI as defined by eGFR level 30-59 mL/min/1.73m^2 based on the MDRD equation, or
- •Severe RI as defined by eGFR level 15-29mL/min/1.73m^2 based on the MDRD equation
排除标准
- •Criteria for All Participants
- •Any clinically significant medical condition or psychiatric condition that may interfere with study intervention
- •Participants with uncontrolled hypertension, asthma, and/or diabetes (Type I or II).
- •Participants with diabetes
- •Participants with any active malignancy
- •Participants with vasculitis or conditions associated with vasculitis.
- •Participants who have undergone major surgery within 12 months of screening
- •Participants with unstable cardiac functions, abnormality, or clinically significant heart failure
- •Participants with infection of HIV, HAV, HBV, HCV, HDV, or HEV
- •Participants with signs of active infection
- •History of bone marrow or solid organ transplantation
- •Participants with end-stage renal disease or nephrotic syndrome as defined by: participants requiring hemodialysis or peritoneal dialysis, participants who have undergone or are listed for transplant, or participants who have chronic kidney disease with nephrotic syndrome
- •Participants with active nephritis
- •Participants with clinically significant liver disease
- •History of drug or alcohol abuse
- •Unwillingness or inability to follow procedures outlined in protocol
- •Exclusion Criteria: Additional Criteria Specific to Healthy Participants
- •Use of any prescription medications or over-the-counter medications (with the exception of vitamins and/or hormonal contraceptive medications) including herbal products within 30 days prior to D1 of study participation
- •Exclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
- •Not on stable dose and regimen of any medication(s) (prescription or over-the-counter) that the participants is taking regularly (eg, medications for chronic conditions such as hypertension, high cholesterol, or depression must not be changed in dose or type for at least 2 weeks prior to study drug administration). Use of other prescription medications or over-the-counter medications that are not for chronic conditions (with the exception of vitamins and/or hormonal contraceptive medications) including herbal products within 30 days prior to D1 of study participation
研究组 & 干预措施
Cohort 1: Up to 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants
Experimental
干预措施: VIR-2218 (Drug)
Cohort 2: Up to 8 severe Renal Impairment (RI) participants and 6 matched healthy participants
Experimental
干预措施: VIR-2218 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
时间窗: 5 days
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
时间窗: 5 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
时间窗: 5 days
Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
时间窗: 5 days
Fraction excreted in urine in percentage for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
时间窗: 5 days
Renal clearance for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
时间窗: 5 days
次要结局
- Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)(Up to 12 weeks)
研究者
研究点 (3)
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