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Pharmacokinetic Interaction Between AZD3480 and Donepezil

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

AZD3480

Donepezil

About this trial

This is an interventional basic science trial for Alzheimer's Disease focused on measuring Healthy volunteers

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

AZD3480 + Donepezil

Outcomes

Primary Outcome Measures

PK variables

Secondary Outcome Measures

Safety variables (adverse events, blood pressure, pulse, safety lab)

Full Information

NCT ID

NCT00713765

First Posted

July 9, 2008

Last Updated

August 12, 2014

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00713765

Brief Title

Pharmacokinetic Interaction Between AZD3480 and Donepezil

Official Title

A Double-blind, Randomised, Cross-over, Placebo-controlled Study of Repeated Oral Doses of AZD3480 and a Single Dose of Donepezil to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Donepezil in Healthy Extensive and Poor Metabolisers of CYP2D6

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Terminated

Why Stopped

Ended prematurely - The trial never commenced.

Study Start Date

December 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Healthy volunteers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD3480 + Donepezil

Intervention Type

Drug

Intervention Name(s)

AZD3480

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Donepezil

Intervention Description

One single dose of mg on day 5

Primary Outcome Measure Information:

Title

PK variables

Time Frame

Frequent sampling occasions during

Secondary Outcome Measure Information:

Title

Safety variables (adverse events, blood pressure, pulse, safety lab)

Time Frame

During the whole treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Göran Hårdemark

Organizational Affiliation

AstraZeneca R&D, Sodertalje, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Simon Constable

Organizational Affiliation

ICON Development Solutions, Manchester, UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1367&filename=D3690C00005.pdf

Description

D3690C00005_No_Results_Certificate

Learn more about this trial

Pharmacokinetic Interaction Between AZD3480 and Donepezil

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