NCT01063556

Brief Summary

The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in subjects with end-state renal disease who were receiving haemodialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 14, 2013

Status Verified

November 1, 2010

Enrollment Period

28 days

First QC Date

February 1, 2010

Last Update Submit

May 13, 2013

Conditions

End-Stage Renal Disease

Keywords

end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics parameter: maximum drug concentration in plasma

    0-48 hours

  • Pharmacokinetics parameter: maximum drug concentration time in plasma

    0-48 hours

  • Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.

    0-48 hours

Study Arms (2)

1

EXPERIMENTAL
Drug: donepezil HCl

2

EXPERIMENTAL
Drug: donepezil HCl

Interventions

donepezil HClDRUG

Subjects will receive donepezil HCL 3 mg without haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg with haemodialysis.

1

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with end-stage renal disease who were receiving haemodialysis. Subject who are able and willing to give written informed consent.

You may not qualify if:

  • Subjects with known hypersensitivity to drugs or foods. Subjects with a corrected QT interval greater than 450 msec at Screening period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Moriya, Ibaraki, Japan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Hirotake Ishigami

    Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 5, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 14, 2013

Record last verified: 2010-11

Locations

JP(1)