Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689559
First received: May 29, 2008
Last updated: June 30, 2009
Last verified: June 2009

May 29, 2008
June 30, 2009
March 2008
Not Provided
PK variables [ Time Frame: Frequent sampling occasions during ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Interventions:
    • Drug: AZD3480
    • Drug: Aripiprazole
  • Experimental: 2
    Placebo + Aripiprazole
    Interventions:
    • 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.
 
Completed
52
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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00689559
D3691C00001, EudraCt nr 2008-000310-74
No
Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje
AstraZeneca
Not Provided
Study Director: Lennart Jeppsson AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Ctril Clarke, MD ICON Development Solutions UK
AstraZeneca
June 2009

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