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Completed

NCT Number: NCT02629224

ASP8825 - Pharmacokinetics Study 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.

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Key information

Conditions

Patients With Impaired Renal Function and Haemodialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP8825

Drug

Oral

Other names: gabapentin enacarbil

Primary outcomes

  1. Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    Cmax: Maximum concentration

  2. PK parameters of gabapentin in plasma: tmax in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    tmax: Time of Cmax

  3. PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing

  4. PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients

    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

    Cmax: Maximum concentration

  5. PK parameters of gabapentin in plasma: tmax in Haemodialysis patients

    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

    tmax: Time of Cmax

  6. PK parameter of gabapentin in plasma: AUC24h in Haemodialysis patients

    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

    AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing

  7. PK parameters of gabapentin in plasma: AUClast in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration

  8. PK parameter of gabapentin in plasma: AUCinf in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

  9. PK parameters of gabapentin in plasma: kel in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    kel: Elimination rate constant

  10. PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    t1/2: Terminal elimination half-life

  11. PK parameters of gabapentin in plasma: CL/F in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    CL/F: Apparent total systemic clearance

  12. PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    Vz/F: Apparent volume of distribution during the terminal elimination phase

  13. PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing

    MRTinf: Mean residence time from the time of dosing extrapolated to time infinity

  14. PK parameters of gabapentin in plasma: t1/2, pre in Haemodialysis patients

    Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hr after dosing

    t1/2, pre: Elimination half-life for pre-hemodialysis

  15. PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients

    Time frame: 24, 25, 26, 27 and 28 hr after dosing

    t1/2,HD: Elimination half-life for hemodialysis

  16. PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients

    Time frame: 30, 36 and 48 hr after dosing

    t1/2, post: Elimination half-life for post-hemodialysis

  17. PK parameters of gabapentin: CLDP in Haemodialysis patients

    Time frame: 25, 26, 27 and 28 hr after dosing

    CLDP: Hemodialysis clearance calculated from the concentration of gabapentin at pre-dialyzer and post-dialyzer

  18. PK parameters of gabapentin in plasma: AUCD in Haemodialysis patients

    Time frame: 24, 25, 26, 27 and 28 hr after dosing

    AUCD: Area under the concentration-time curve from the start to end of haemodialysis the concentration of gabapentin in plasma pre-dialyzer

  19. PK parameters of gabapentin in urine: Ae72h in Renal impairment patients

    Time frame: Up to 72 hr after dosing

    Ae72h: Amount of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing

  20. PK parameters of gabapentin in urine: Ae%72h in Renal impairment patients

    Time frame: Up to 72 hr after dosing

    Ae%72h: Percent of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing

  21. PK parameters of gabapentin in urine: CLR in Renal impairment patients

    Time frame: Up to 72 hr after dosing

    CLR: Renal clearance

  22. PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients

    Time frame: Up to 48 hr after dosing

    Ae48h: Amount of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing

  23. PK parameters of gabapentin in urine: Ae%48h in Haemodialysis patients

    Time frame: Up to 48 hr after dosing

    Ae%48h: Percent of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing

  24. PK parameters of gabapentin in dialyzing fluid: Adt in Haemodialysis patients

    Time frame: Up to 48 hr after dosing

    Adt: Cumulative amount in dialyzing fluid from the time of dosing to time after dosing

  25. PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients

    Time frame: Up to 48 hr after dosing

    Adt%: Excretion rate in dialyzing fluid

  26. PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients

    Time frame: Up to 48 hr after dosing

    CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid

  27. Safety assessed by AEs

    Time frame: Up to 7 days after the study drug dosing

    AEs: Adverse Events

  28. Safety assessed by Vital signs

    Time frame: Up to 7 days after the study drug dosing

    Supine blood pressure, supine pulse rate and axillary body temperature

  29. Safety assessed by Laboratory tests

    Time frame: Up to 7 days after the study drug dosing

    Hematology, blood biochemistry, and urinalysis

  30. Safety assessed by 12-lead ECGs

    Time frame: Up to 7 days after the study drug dosing

    ECG: Electrocardiogram

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 14, 2015
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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