Clinical trial NCT02629224: ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
Official title: Pharmacokinetic (PK) Study of ASP8825 - Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Haemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Patients With Impaired Renal Function and Haemodialysis
Keywords: Impaired renal function
Haemodialysis
ASP8825
XP13512
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-12-14
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameters of gabapentin in plasma: tmax in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients
timeFrame: 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
measure: PK parameters of gabapentin in plasma: tmax in Haemodialysis patients
timeFrame: 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
measure: PK parameter of gabapentin in plasma: AUC24h in Haemodialysis patients
timeFrame: 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
measure: PK parameters of gabapentin in plasma: AUClast in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameter of gabapentin in plasma: AUCinf in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameters of gabapentin in plasma: kel in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameters of gabapentin in plasma: CL/F in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
measure: PK parameters of gabapentin in plasma: t1/2, pre in Haemodialysis patients
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hr after dosing
measure: PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients
timeFrame: 24, 25, 26, 27 and 28 hr after dosing
measure: PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients
timeFrame: 30, 36 and 48 hr after dosing
measure: PK parameters of gabapentin: CLDP in Haemodialysis patients
timeFrame: 25, 26, 27 and 28 hr after dosing
measure: PK parameters of gabapentin in plasma: AUCD in Haemodialysis patients
timeFrame: 24, 25, 26, 27 and 28 hr after dosing
measure: PK parameters of gabapentin in urine: Ae72h in Renal impairment patients
timeFrame: Up to 72 hr after dosing
measure: PK parameters of gabapentin in urine: Ae%72h in Renal impairment patients
timeFrame: Up to 72 hr after dosing
measure: PK parameters of gabapentin in urine: CLR in Renal impairment patients
timeFrame: Up to 72 hr after dosing
measure: PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients
timeFrame: Up to 48 hr after dosing
measure: PK parameters of gabapentin in urine: Ae%48h in Haemodialysis patients
timeFrame: Up to 48 hr after dosing
measure: PK parameters of gabapentin in dialyzing fluid: Adt in Haemodialysis patients
timeFrame: Up to 48 hr after dosing
measure: PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients
timeFrame: Up to 48 hr after dosing
measure: PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients
timeFrame: Up to 48 hr after dosing
measure: Safety assessed by AEs
timeFrame: Up to 7 days after the study drug dosing
measure: Safety assessed by Vital signs
timeFrame: Up to 7 days after the study drug dosing
measure: Safety assessed by Laboratory tests
timeFrame: Up to 7 days after the study drug dosing
measure: Safety assessed by 12-lead ECGs
timeFrame: Up to 7 days after the study drug dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: