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The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal impairment | Experimental |
| |
| Haemodialysis | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8825 | Drug | Oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients | Cmax: Maximum concentration | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameters of gabapentin in plasma: tmax in Renal impairment patients | tmax: Time of Cmax | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients | AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients | Cmax: Maximum concentration | 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 |
| PK parameters of gabapentin in plasma: tmax in Haemodialysis patients | tmax: Time of Cmax | 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 |
| PK parameter of gabapentin in plasma: AUC24h in Haemodialysis patients | AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing | 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 |
| PK parameters of gabapentin in plasma: AUClast in Renal impairment patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C493250 | 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid |
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AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration |
| Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameter of gabapentin in plasma: AUCinf in Renal impairment patients | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameters of gabapentin in plasma: kel in Renal impairment patients | kel: Elimination rate constant | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients | t1/2: Terminal elimination half-life | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameters of gabapentin in plasma: CL/F in Renal impairment patients | CL/F: Apparent total systemic clearance | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients | Vz/F: Apparent volume of distribution during the terminal elimination phase | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients | MRTinf: Mean residence time from the time of dosing extrapolated to time infinity | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing |
| PK parameters of gabapentin in plasma: t1/2, pre in Haemodialysis patients | t1/2, pre: Elimination half-life for pre-hemodialysis | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hr after dosing |
| PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients | t1/2,HD: Elimination half-life for hemodialysis | 24, 25, 26, 27 and 28 hr after dosing |
| PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients | t1/2, post: Elimination half-life for post-hemodialysis | 30, 36 and 48 hr after dosing |
| PK parameters of gabapentin: CLDP in Haemodialysis patients | CLDP: Hemodialysis clearance calculated from the concentration of gabapentin at pre-dialyzer and post-dialyzer | 25, 26, 27 and 28 hr after dosing |
| PK parameters of gabapentin in plasma: AUCD in Haemodialysis patients | AUCD: Area under the concentration-time curve from the start to end of haemodialysis the concentration of gabapentin in plasma pre-dialyzer | 24, 25, 26, 27 and 28 hr after dosing |
| PK parameters of gabapentin in urine: Ae72h in Renal impairment patients | Ae72h: Amount of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing | Up to 72 hr after dosing |
| PK parameters of gabapentin in urine: Ae%72h in Renal impairment patients | Ae%72h: Percent of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing | Up to 72 hr after dosing |
| PK parameters of gabapentin in urine: CLR in Renal impairment patients | CLR: Renal clearance | Up to 72 hr after dosing |
| PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients | Ae48h: Amount of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing | Up to 48 hr after dosing |
| PK parameters of gabapentin in urine: Ae%48h in Haemodialysis patients | Ae%48h: Percent of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing | Up to 48 hr after dosing |
| PK parameters of gabapentin in dialyzing fluid: Adt in Haemodialysis patients | Adt: Cumulative amount in dialyzing fluid from the time of dosing to time after dosing | Up to 48 hr after dosing |
| PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients | Adt%: Excretion rate in dialyzing fluid | Up to 48 hr after dosing |
| PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients | CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid | Up to 48 hr after dosing |
| Safety assessed by AEs | AEs: Adverse Events | Up to 7 days after the study drug dosing |
| Safety assessed by Vital signs | Supine blood pressure, supine pulse rate and axillary body temperature | Up to 7 days after the study drug dosing |
| Safety assessed by Laboratory tests | Hematology, blood biochemistry, and urinalysis | Up to 7 days after the study drug dosing |
| Safety assessed by 12-lead ECGs | ECG: Electrocardiogram | Up to 7 days after the study drug dosing |
| Tokyo |
| Japan |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |