Study Stopped
Ended prematurely - The trial never commenced.
Pharmacokinetic Interaction Between AZD3480 and Donepezil
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
2 other identifiers
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2008
1 active site
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
July 9, 2008
CompletedFirst Posted
Study publicly available on registry
July 11, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedAugust 15, 2014
August 1, 2014
Same day
July 9, 2008
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK variables
Frequent sampling occasions during
Secondary Outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
During the whole treatment period
Study Arms (1)
A
EXPERIMENTALAZD3480 + Donepezil
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Manchester, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans Göran Hårdemark
AstraZeneca R&D, Sodertalje, Sweden
- PRINCIPAL INVESTIGATOR
Simon Constable
ICON Development Solutions, Manchester, UK
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2008
First Posted
July 11, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 15, 2014
Record last verified: 2014-08