Pharmacokinetic Interaction Between AZD3480 and Donepezil

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00713765
• Other study ID #: D3690C00005
• Secondary ID: EudraCt No.2008-
• Status: Terminated
• Phase: Phase 1
• First received: July 9, 2008
• Last updated: August 12, 2014
• Start date: December 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AZD3480
18 total doses of 40 mg, on days 1-18
• Donepezil
One single dose of mg on day 5

Locations

Country	Name	City	State
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment period	Yes

External Links

•   D3690C00005_No_Results_Certificate