Patients With Impaired Renal Function and Haemodialysis
Conditions
Keywords
Impaired renal function, Haemodialysis, ASP8825, XP13512
Brief summary
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
Interventions
DRUGASP8825
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients | 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 parameter of gabapentin in plasma: Cmax in Haemodialysis patients | 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 parameters of gabapentin in plasma: tmax in Haemodialysis patients | 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 |
| Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients | 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 parameters of gabapentin in plasma: tmax in Renal impairment patients | 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 parameter of gabapentin in plasma: AUC24h in Haemodialysis patients | 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 |
| PK parameters of gabapentin in plasma: AUClast in Renal impairment patients | 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 parameter of gabapentin in plasma: AUCinf in Renal impairment patients | 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 | 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 | 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 | 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: Vz/F in Renal impairment patients | 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: MRTinf in Renal impairment patients | 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 | 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, HD in Haemodialysis patients | 24, 25, 26, 27 and 28 hr after dosing | t1/2,HD: Elimination half-life for hemodialysis |
| PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients | 30, 36 and 48 hr after dosing | t1/2, post: Elimination half-life for post-hemodialysis |
| PK parameters of gabapentin: CLDP in Haemodialysis patients | 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 plasma: AUCD in Haemodialysis patients | 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 urine: Ae72h in Renal impairment patients | 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 | 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 | Up to 72 hr after dosing | CLR: Renal clearance |
| PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients | 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 | 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 | Up to 48 hr after dosing | Adt: Cumulative amount in dialyzing fluid from the time of dosing to time after dosing |
| PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients | Up to 48 hr after dosing | Adt%: Excretion rate in dialyzing fluid |
| PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients | Up to 48 hr after dosing | CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid |
| Safety assessed by AEs | Up to 7 days after the study drug dosing | AEs: Adverse Events |
| Safety assessed by Vital signs | Up to 7 days after the study drug dosing | Supine blood pressure, supine pulse rate and axillary body temperature |
| Safety assessed by Laboratory tests | Up to 7 days after the study drug dosing | Hematology, blood biochemistry, and urinalysis |
| Safety assessed by 12-lead ECGs | Up to 7 days after the study drug dosing | ECG: Electrocardiogram |
Countries
Japan
Outcome results
None listed