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

NCT02629224 | Completed Phase 1

• 1 other identifier: 8825-CL-0012
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Patients With Impaired Renal Function and Haemodialysis

Keywords

Impaired renal function; Haemodialysis; ASP8825; XP13512

Outcome Measures

Primary Outcomes (30)

• 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 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

Study Arms (2)

Renal impairment

EXPERIMENTAL

Drug: ASP8825

Haemodialysis

EXPERIMENTAL

Drug: ASP8825

Interventions

ASP8825 DRUG

Oral

Also known as: gabapentin enacarbil

Haemodialysis; Renal impairment

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Conditions

Renal Insufficiency

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

JP (2)