Back to resultsASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
Primary Purpose
Patients With Impaired Renal Function and Haemodialysis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ASP8825
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Impaired Renal Function and Haemodialysis focused on measuring Impaired renal function, Haemodialysis, ASP8825, XP13512
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Renal impairment
Haemodialysis
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients
Cmax: Maximum concentration
PK parameters of gabapentin in plasma: tmax in Renal impairment patients
tmax: Time of Cmax
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
PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients
Cmax: Maximum concentration
PK parameters of gabapentin in plasma: tmax in Haemodialysis patients
tmax: Time of Cmax
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
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
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
PK parameters of gabapentin in plasma: kel in Renal impairment patients
kel: Elimination rate constant
PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients
t1/2: Terminal elimination half-life
PK parameters of gabapentin in plasma: CL/F in Renal impairment patients
CL/F: Apparent total systemic clearance
PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients
Vz/F: Apparent volume of distribution during the terminal elimination phase
PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients
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
t1/2, pre: Elimination half-life for pre-hemodialysis
PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients
t1/2,HD: Elimination half-life for hemodialysis
PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients
t1/2, post: Elimination half-life for post-hemodialysis
PK parameters of gabapentin: CLDP in Haemodialysis patients
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
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
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
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
CLR: Renal clearance
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
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
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
PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients
Adt%: Excretion rate in dialyzing fluid
PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients
CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid
Safety assessed by AEs
AEs: Adverse Events
Safety assessed by Vital signs
Supine blood pressure, supine pulse rate and axillary body temperature
Safety assessed by Laboratory tests
Hematology, blood biochemistry, and urinalysis
Safety assessed by 12-lead ECGs
ECG: Electrocardiogram
Secondary Outcome Measures
Full Information
NCT ID
NCT02629224
First Posted
December 10, 2015
Last Updated
February 3, 2016
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT02629224
Brief Title
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
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Impaired Renal Function and Haemodialysis
Keywords
Impaired renal function, Haemodialysis, ASP8825, XP13512
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal impairment
Arm Type
Experimental
Arm Title
Haemodialysis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASP8825
Other Intervention Name(s)
gabapentin enacarbil
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients
Description
Cmax: Maximum concentration
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameters of gabapentin in plasma: tmax in Renal impairment patients
Description
tmax: Time of Cmax
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients
Description
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients
Description
Cmax: Maximum concentration
Time Frame
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
Title
PK parameters of gabapentin in plasma: tmax in Haemodialysis patients
Description
tmax: Time of Cmax
Time Frame
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
Title
PK parameter of gabapentin in plasma: AUC24h in Haemodialysis patients
Description
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Time Frame
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
Title
PK parameters of gabapentin in plasma: AUClast in Renal impairment patients
Description
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameter of gabapentin in plasma: AUCinf in Renal impairment patients
Description
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameters of gabapentin in plasma: kel in Renal impairment patients
Description
kel: Elimination rate constant
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients
Description
t1/2: Terminal elimination half-life
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameters of gabapentin in plasma: CL/F in Renal impairment patients
Description
CL/F: Apparent total systemic clearance
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients
Description
Vz/F: Apparent volume of distribution during the terminal elimination phase
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients
Description
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Title
PK parameters of gabapentin in plasma: t1/2, pre in Haemodialysis patients
Description
t1/2, pre: Elimination half-life for pre-hemodialysis
Time Frame
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hr after dosing
Title
PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients
Description
t1/2,HD: Elimination half-life for hemodialysis
Time Frame
24, 25, 26, 27 and 28 hr after dosing
Title
PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients
Description
t1/2, post: Elimination half-life for post-hemodialysis
Time Frame
30, 36 and 48 hr after dosing
Title
PK parameters of gabapentin: CLDP in Haemodialysis patients
Description
CLDP: Hemodialysis clearance calculated from the concentration of gabapentin at pre-dialyzer and post-dialyzer
Time Frame
25, 26, 27 and 28 hr after dosing
Title
PK parameters of gabapentin in plasma: AUCD in Haemodialysis patients
Description
AUCD: Area under the concentration-time curve from the start to end of haemodialysis the concentration of gabapentin in plasma pre-dialyzer
Time Frame
24, 25, 26, 27 and 28 hr after dosing
Title
PK parameters of gabapentin in urine: Ae72h in Renal impairment patients
Description
Ae72h: Amount of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
Time Frame
Up to 72 hr after dosing
Title
PK parameters of gabapentin in urine: Ae%72h in Renal impairment patients
Description
Ae%72h: Percent of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
Time Frame
Up to 72 hr after dosing
Title
PK parameters of gabapentin in urine: CLR in Renal impairment patients
Description
CLR: Renal clearance
Time Frame
Up to 72 hr after dosing
Title
PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients
Description
Ae48h: Amount of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
Time Frame
Up to 48 hr after dosing
Title
PK parameters of gabapentin in urine: Ae%48h in Haemodialysis patients
Description
Ae%48h: Percent of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
Time Frame
Up to 48 hr after dosing
Title
PK parameters of gabapentin in dialyzing fluid: Adt in Haemodialysis patients
Description
Adt: Cumulative amount in dialyzing fluid from the time of dosing to time after dosing
Time Frame
Up to 48 hr after dosing
Title
PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients
Description
Adt%: Excretion rate in dialyzing fluid
Time Frame
Up to 48 hr after dosing
Title
PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients
Description
CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid
Time Frame
Up to 48 hr after dosing
Title
Safety assessed by AEs
Description
AEs: Adverse Events
Time Frame
Up to 7 days after the study drug dosing
Title
Safety assessed by Vital signs
Description
Supine blood pressure, supine pulse rate and axillary body temperature
Time Frame
Up to 7 days after the study drug dosing
Title
Safety assessed by Laboratory tests
Description
Hematology, blood biochemistry, and urinalysis
Time Frame
Up to 7 days after the study drug dosing
Title
Safety assessed by 12-lead ECGs
Description
ECG: Electrocardiogram
Time Frame
Up to 7 days after the study drug dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Fukuoka
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=8825-CL-0012
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
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