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

NCT ID: NCT02629224

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal impairment

Group Type: EXPERIMENTAL

ASP8825

Intervention Type: DRUG

Oral

Haemodialysis

Group Type: EXPERIMENTAL

ASP8825

Intervention Type: DRUG

Oral

Interventions

ASP8825

Oral

Intervention Type: DRUG

Other Intervention Names

gabapentin enacarbil

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Fukuoka, , Japan

Tokyo, , Japan

Countries

Japan

Related Links

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=8825-CL-0012

Link to results on Astellas Clinical Study Results Web site

Other Identifiers

8825-CL-0012

Identifier Type: -

Identifier Source: org_study_id