Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD3480
Placebo
Aripiprazole
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease focused on measuring Alzheimer's disease, AZD3480, Aripiprazole
Eligibility Criteria
Inclusion Criteria:
- Provision of signed written informed consent
- Clinically normal physical findings and laboratory values
Exclusion Criteria:
- Clinically significant illness or clinically relevant trauma within three weeks before the first dose
- History of clinically significant disease
- Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
AZD3480 + Aripiprazole
Placebo + Aripiprazole
Outcomes
Primary Outcome Measures
PK variables
Secondary Outcome Measures
Safety variables (adverse events, blood pressure, pulse, safety lab)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689559
Brief Title
Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects
Official Title
A Single-Centre, Double-Blind, Randomised, Parallel Group Study of Repeated Oral Doses of AZD3480/Placebo and a Single Dose of Aripiprazole to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Aripiprazole in Healthy Subjects (Phase I)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, AZD3480, Aripiprazole
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD3480 + Aripiprazole
Arm Title
2
Arm Type
Experimental
Arm Description
Placebo + Aripiprazole
Intervention Type
Drug
Intervention Name(s)
AZD3480
Intervention Description
AZD3480 capsules qd, oral, 22 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo qd, 12 days
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
single dose 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
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of signed written informed consent
Clinically normal physical findings and laboratory values
Exclusion Criteria:
Clinically significant illness or clinically relevant trauma within three weeks before the first dose
History of clinically significant disease
Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Jeppsson
Organizational Affiliation
AstraZeneca R&D, Södertälje, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ctril Clarke, MD
Organizational Affiliation
ICON Development Solutions UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects
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