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Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00689559
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : July 2, 2009
Information provided by:

May 29, 2008
June 3, 2008
July 2, 2009
March 2008
Not Provided
PK variables [ Time Frame: Frequent sampling occasions during ]
Same as current
Complete list of historical versions of study NCT00689559 on ClinicalTrials.gov Archive Site
Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]
Same as current
Not Provided
Not Provided
Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects
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)
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Alzheimer's Disease
  • Drug: AZD3480
    AZD3480 capsules qd, oral, 22 days
  • Drug: Placebo
    Placebo qd, 12 days
  • Drug: Aripiprazole
    single dose on day 5
    Other Name: Abilify
  • Experimental: 1
    AZD3480 + Aripiprazole
    • Drug: AZD3480
    • Drug: Aripiprazole
  • Experimental: 2
    Placebo + Aripiprazole
    • Drug: Placebo
    • Drug: Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2009
Not Provided

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCt nr 2008-000310-74
Not Provided
Not Provided
Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje
Not Provided
Study Director: Lennart Jeppsson AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Ctril Clarke, MD ICON Development Solutions UK
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP