Pharmacokinetic Interaction Between AZD3480 and Donepezil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2008-12-31

Brief Summary

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The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood concentrations of each other and 2) assess the safety and tolerability of the combined administration of AZD3480 with donepezil.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

AZD3480 + Donepezil

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

18 total doses of 40 mg, on days 1-18

Donepezil

Intervention Type DRUG

One single dose of mg on day 5

Interventions

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AZD3480

18 total doses of 40 mg, on days 1-18

Intervention Type DRUG

Donepezil

One single dose of mg on day 5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study-specific procedures
* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Genotyped as an EM, defined in this study as having ≥ 1.5 functional CYP2D6 alleles, or a PM, defined as having zero functional CYP2D6 alleles

Exclusion Criteria

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes