NCT07758608尚未招募1 期
An Open-Label, Adaptive Single-Dose Trial to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Afabicin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Afabicin Desphosphono
研究概览
简要总结
The primary purpose of this study is to assess the effect of renal impairment on the PK of afabicin desphosphono after a single oral 80 milligrams (mg) or intravenous (IV) 55 mg dose of afabicin.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
- •Body Mass Index (BMI): 18.5 to 35.0 kilograms per square meter (kg/m^2), inclusive, at screening.
- •Nonsmoker (confirmed by urine cotinine <500 nanograms per milliliter (ng/mL)) and have not used nicotine or nicotine containing products for the last month before screening.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
- •Stable renal function. Renal function must be considered stable by the Investigator. The screening eGFR, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula and adjusted for body surface area (multiplied by individual BSA/1.73 m^2), will be used for group allocation:
- •For participants with normal renal function: eGFR ≥90 mL/min
- •For participants with mild renal impairment: eGFR ≥60 to <90 mL/min
- •For participants with moderate renal impairment: eGFR ≥30 to <60 mL/min
- •For participants with severe renal impairment and kidney failure not receiving dialysis: eGFR <30 mL/min
- •Confirmation of renal function prior to dosing. Renal function stability must be confirmed on Day -
- •The eGFR determined on Day -1, obtained at least 3 days apart from screening, must not deviate by more than 25 percent (%) from the eGFR value obtained at screening.
排除标准
- •Any clinically significant symptoms of an infectious illness (bacterial, viral or parasitic) within 2 weeks prior to first dosing or a history of recurrent infections (≥3 infections requiring medical intervention in the 6 months prior to ICF signature).
- •History of chronic drug or alcohol abuse in the last 4 years.
- •A positive result in the alcohol and/or urine drug abuse evaluations at screening or admission on Day -1, unless the result is attributable to a prescribed medication used to treat comorbidities associated with chronic kidney disease or another stable condition.
- •History of investigational medication use within 3 months or 5 half-lives of the drug (whichever is longer) prior to administration the trial drug.
- •Blood loss or donation of blood over 500 milliliter (mL) within 3 months prior to screening.
- •Uncontrolled hypertension, defined as systolic blood pressure greater than (>)160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg on average of 3 measurements at screening. Screening measurements should be conducted with participants on baseline anti-hypertensive regimen.
- •History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal (for participants with normal renal function), hepatic, neurological, gastrointestinal, endocrine, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk due to participation in the trial, influence the results of the trial, or influence the participant's ability to participate in the trial.
- •History of uric acid stone disease in the last 5 years.
- •History of chronic pancreatitis or idiopathic acute pancreatitis.
- •Participants with renal transplant or renal carcinoma (participants with a history of renal carcinoma could be included if cancer free for >10 years).
- •A potassium concentration >6.1 millimoles per liter (mmol/L) at screening or Day -
- •Plasma albumin <3.0 grams per deciliter (g/dL) and/or proteinuria >3.5 grams per day (g/day) at screening.
- •A history of nephrotic syndrome.
- •Note: Other protocol-specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group 1
Experimental
Participants with normal renal function: estimated Glomerular Filtration Rate (eGFR) greater than or equal to (≥) 90 milliliters per minute (mL/min) will be administered a single dose of afabicin on Day 1.
干预措施: Afabicin Oral (Drug)
Group 2
Experimental
Participants with mild renal impairment: eGFR 60 to less than (<) 90 mL/min will be administered a single dose of afabicin on Day 1.
干预措施: Afabicin Oral (Drug)
Group 3
Experimental
Participants with moderate renal impairment: eGFR 30 to <60 mL/min will be administered a single dose of afabicin on Day 1.
干预措施: Afabicin Oral (Drug)
Group 4
Experimental
Participants with severe renal impairment and kidney failure not receiving dialysis: eGFR <30 mL/min will be administered a single dose of afabicin on Day 1.
干预措施: Afabicin Oral (Drug)
Group 5
Active Comparator
Participants with renal impairment will be administered a single IV dose of afabicin on Day 1.
干预措施: Afabicin IV (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Afabicin Desphosphono
时间窗: From predose and at multiple timepoints (up to Day 5) post dose
次要结局
- Maximum Observed Plasma Concentration (Cmax) of Afabicin Desphosphono(From predose and at multiple timepoints (up to Day 5) post dose)
- Area Under the Plasma Concentration-Time Curve to the Last Quantifiable Concentration (AUClast) of Afabicin Desphosphono(From predose and at multiple timepoints (up to Day 5) post dose)
- Time of Maximum Observed Plasma Concentration (tmax) of Afabicin Desphosphono(From predose and at multiple timepoints (up to Day 5) post dose)
- Apparent Plasma Terminal Elimination Half-Life (t1/2) of Afabicin Desphosphono(From predose and at multiple timepoints (up to Day 5) post dose)
- Apparent Total Body Clearance From the Plasma (Cl/F or Cl) of Afabicin Desphosphono(From predose and at multiple timepoints (up to Day 5) post dose)
- Fraction Unbound (fu) of Afabicin Desphosphono(From predose and at multiple timepoints (up to Day 5) post dose)
- Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)(From first dose of the study drug up to the end of the follow-up (up to Day 10))
研究者
研究点 (1)
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