ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis

Pharmacokinetic (PK) Study of ASP8825 - Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Haemodialysis

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

Study Overview

• Status: Completed
• Conditions: Patients With Impaired Renal Function and Haemodialysis
• Intervention / Treatment: Drug: ASP8825

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal impairment	Drug: ASP8825; Oral; Other Names: gabapentin enacarbil
Experimental: Haemodialysis	Drug: ASP8825; Oral; Other Names: gabapentin enacarbil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 12-lead ECGs	ECG: Electrocardiogram	Up to 7 days after the study drug dosing
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	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 Laboratory tests	Hematology, blood biochemistry, and urinalysis	Up to 7 days after the study drug dosing

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (Estimate): December 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Impaired renal function; Haemodialysis; ASP8825; XP13512
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 8825-CL-0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED