A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Maximum Observed concentration (Cmax) of Pimodivir
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of pimodivir after a single oral dose of 600 milligrams (mg) in adult participants with severe renal impairment who are not on dialysis and in adult participants with end-stage renal disease (ESRD) who are not yet on dialysis compared to adult participants with normal renal function (Part A). Optionally, to evaluate the PK in adult participants with mild and/or moderate renal impairment compared to adult participants with normal renal function (Part B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must have a body mass index (Body Mass Index [BMI]; body weight (Kilograms per height^2 [kg/m^2]) between 18.0 and 38.0 kg/m^2, inclusive, and body weight not less than 50 kg, inclusive, at screening
- •Participants with normal renal function must have normal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (less than or equal to [<=]1.5*upper limit of laboratory normal range [ULN]) at screening and Day -1 and participants with renal impairment and end-stage renal disease (ESRD) must have values for ALT and AST <=3.0*ULN at screening and Day -1
- •Participants with normal renal function must have glomerular filtration rate (GFR) greater than or equal to (>=) 90 milliliters per minute (mL/min) and participants with renal impairment (mild, moderate and severe) and ESRD must have >=60 mL/min to <90 mL/min (for Mild renal impairment); >=30 to <60 mL/min (for Moderate renal impairment); >=15 mL/min to <30 mL/min (for Severe renal impairment not on dialysis); and <15 mL/min (for ESRD not on dialysis)
- •Participants with normal renal function must have a systolic blood pressure (after the participant is supine for 5 minutes) between 90 millimeters of mercury (mmHg), extremes included, and diastolic blood pressure no higher than 90 mmHg and participants with renal impairment (mild, moderate and severe) and ESRD must have a systolic blood pressure (after the participant is supine for 5 minutes) between 90 and 159 mmHg, extremes included, and diastolic blood pressure no higher than 99 mmHg. If blood pressure is out of range, 1 repeated assessment is permitted after an additional 5 minutes of rest
- •A woman, except if postmenopausal, must have a negative highly sensitive serum pregnancy test (beta human chorionic gonadotropin [beta hCG]) at screening and a negative urine pregnancy test on Day -1
排除标准
- •Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (for example [e.g.], Crohn's disease), with the exception of renal impairment
- •Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or any other clinically active liver disease at screening
- •Participant has a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillin, or drug allergy diagnosed in previous studies with experimental drugs
- •Participant has known allergies, hypersensitivity, or intolerance to pimodivir or its excipients
- •Participant has evidence of an active infection
研究组 & 干预措施
Part A: Normal renal function (control group)
Participants with normal renal function (glomerular filtration rate [GFR] greater than or equal to [>=] 90 milliliters per minute [mL/min]) will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
干预措施: Pimodivir (Drug)
Part A: Severe renal impairment or ESRD
Participants with severe renal impairment (GFR >=15 to less than [<]30 mL/min) who are not on dialysis or end stage renal disease (ESRD) (GFR <15 mL/min) not yet on dialysis will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
干预措施: Pimodivir (Drug)
Part B (Optional): Mild renal impairment
Participants with mild renal impairment (GFR >=60 mL/min to <90 mL/min) will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
干预措施: Pimodivir (Drug)
Part B (Optional): Moderate renal impairment
Participants with moderate renal impairment (GFR >=30 to <60 mL/min) will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
干预措施: Pimodivir (Drug)
结局指标
主要结局
Maximum Observed concentration (Cmax) of Pimodivir
时间窗: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6
Cmax is the maximum observed concentration.
Area Under Curve From Time of Dosing to the Time of the last Measurable Concentration (AUC[0-last]) of Pimodivir
时间窗: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6
AUC(0-last) is the AUC from time of dosing to the time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
AUC from time of dosing to infinity (AUC[0-infinity]) of Pimodivir
时间窗: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6
AUC(0-infinity) is the AUC from time of dosing to infinity, calculated as AUC(0-last) + Clast/ (lambda\[z\]), where Clast is the last observed measurable concentration and lambda(z) is the apparent terminal elimination rate constant.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 42 (+/-) 2 days)