Pharmacokinetic (PK) Study of ASP8825 - Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Haemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- PK parameters of gabapentin in plasma: tmax in Renal impairment patients
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight: ≥40.0 kg and <80.0 kg
- •Body mass index BMI: ≥16.0 and <30.0 [BMI= Body weight (kg)/(Height (m))2]
- •For Renal impairment patients: Patients with eGFR by GFR predictive equation for Japanese within < 50 mL.min/1.73m2 at screening and who is not undergoing dialysis
- •For Haemodialysis patients: Patients who receive dialysis at screening
- •Patients whose treatment regimen (including diet) for renal impairment or complications remain unchanged within 14 days prior to dosing, or patients who receive treatments (including diet) that need not to be changed during the period from 14 days before dosing to follow-up examination in the opinion of the investigator or sub-investigator.
- •Female subjects who agree use effective contraception starting at informed consent and throughout the study period
排除标准
- •Patients with a complication or history of the inappropriate for this study (except for a complication of primary disease for renal dysfunction, like diabetes etc., or complication of hypertension or anemia etc.)
- •Patients with a complication or history of recurring alimentary disease
- •Patients with a history of gastrointestinal surgical operation
- •Patients with a complication of severe heart disease
- •Patients with a complication or history of malignant tumor (However, a patient without recurrence of the malignant tumor for more than 5 years after the treatment may be eligible for the study.)
- •Patients judged ineligible by the investigator or sub-investigator based on the results of medical examination, vital sign, 12-ECG and laboratory test
- •Patients who have an Hb value <9g/dL at screening
- •Patients who received or are scheduled to receive any study drugs in other clinical trials or post-marketing studies within 120 days before screening
- •Patients who received or are scheduled to receive medications within seven days before the dosing of the investigational drug
- •Patients who previously received administration of Gabapentin or ASP8825
研究组 & 干预措施
Renal impairment
干预措施: ASP8825 (Drug)
Haemodialysis
干预措施: ASP8825 (Drug)
结局指标
主要结局
PK parameters of gabapentin in plasma: tmax in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
tmax: Time of Cmax
PK parameters of gabapentin in plasma: tmax in Haemodialysis patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
tmax: Time of Cmax
PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
Cmax: Maximum concentration
PK parameter of gabapentin in plasma: AUC24h in Haemodialysis patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Cmax: Maximum concentration
PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Vz/F: Apparent volume of distribution during the terminal elimination phase
PK parameters of gabapentin in plasma: AUClast in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
PK parameters of gabapentin in dialyzing fluid: Adt in Haemodialysis patients
时间窗: Up to 48 hr after dosing
Adt: Cumulative amount in dialyzing fluid from the time of dosing to time after dosing
PK parameter of gabapentin in plasma: AUCinf in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameters of gabapentin in plasma: kel in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
kel: Elimination rate constant
PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
t1/2: Terminal elimination half-life
PK parameters of gabapentin in plasma: CL/F in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
CL/F: Apparent total systemic clearance
PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients
时间窗: 24, 25, 26, 27 and 28 hr after dosing
t1/2,HD: Elimination half-life for hemodialysis
PK parameters of gabapentin in plasma: AUCD in Haemodialysis patients
时间窗: 24, 25, 26, 27 and 28 hr after dosing
AUCD: Area under the concentration-time curve from the start to end of haemodialysis the concentration of gabapentin in plasma pre-dialyzer
PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
PK parameters of gabapentin in plasma: t1/2, pre in Haemodialysis patients
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hr after dosing
t1/2, pre: Elimination half-life for pre-hemodialysis
PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients
时间窗: 30, 36 and 48 hr after dosing
t1/2, post: Elimination half-life for post-hemodialysis
PK parameters of gabapentin: CLDP in Haemodialysis patients
时间窗: 25, 26, 27 and 28 hr after dosing
CLDP: Hemodialysis clearance calculated from the concentration of gabapentin at pre-dialyzer and post-dialyzer
PK parameters of gabapentin in urine: Ae72h in Renal impairment patients
时间窗: Up to 72 hr after dosing
Ae72h: Amount of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
PK parameters of gabapentin in urine: Ae%72h in Renal impairment patients
时间窗: Up to 72 hr after dosing
Ae%72h: Percent of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
PK parameters of gabapentin in urine: CLR in Renal impairment patients
时间窗: Up to 72 hr after dosing
CLR: Renal clearance
PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients
时间窗: Up to 48 hr after dosing
Ae48h: Amount of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
PK parameters of gabapentin in urine: Ae%48h in Haemodialysis patients
时间窗: Up to 48 hr after dosing
Ae%48h: Percent of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients
时间窗: Up to 48 hr after dosing
Adt%: Excretion rate in dialyzing fluid
PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients
时间窗: Up to 48 hr after dosing
CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid
Safety assessed by AEs
时间窗: Up to 7 days after the study drug dosing
AEs: Adverse Events
Safety assessed by Vital signs
时间窗: Up to 7 days after the study drug dosing
Supine blood pressure, supine pulse rate and axillary body temperature
Safety assessed by Laboratory tests
时间窗: Up to 7 days after the study drug dosing
Hematology, blood biochemistry, and urinalysis
Safety assessed by 12-lead ECGs
时间窗: Up to 7 days after the study drug dosing
ECG: Electrocardiogram
次要结局
未报告次要终点