Patients With Impaired Renal Function and Haemodialysis Clinical Trial
Official title:
Pharmacokinetic (PK) Study of ASP8825 - Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Haemodialysis
| Verified date | February 2016 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
| Study type | Interventional |
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 79 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | PK parameters of gabapentin in plasma: AUClast in Renal impairment patients | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | PK parameters of gabapentin in urine: CLR in Renal impairment patients | CLR: Renal clearance | Up to 72 hr after dosing | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients | Adt%: Excretion rate in dialyzing fluid | Up to 48 hr after dosing | No |
| Primary | 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 | No |
| Primary | Safety assessed by AEs | AEs: Adverse Events | Up to 7 days after the study drug dosing | No |
| Primary | Safety assessed by Vital signs | Supine blood pressure, supine pulse rate and axillary body temperature | Up to 7 days after the study drug dosing | No |
| Primary | Safety assessed by Laboratory tests | Hematology, blood biochemistry, and urinalysis | Up to 7 days after the study drug dosing | No |
| Primary | Safety assessed by 12-lead ECGs | ECG: Electrocardiogram | Up to 7 days after the study drug dosing | No |