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Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

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

Condition Intervention Phase
Alzheimer's Disease Drug: AZD3480 Drug: Placebo Drug: Aripiprazole Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]

Estimated Enrollment: 52
Study Start Date: March 2008
Study Completion Date: April 2009
Arms Assigned Interventions
Experimental: 1
AZD3480 + Aripiprazole
Drug: AZD3480
AZD3480 capsules qd, oral, 22 days
Drug: Aripiprazole
single dose on day 5
Other Name: Abilify
Experimental: 2
Placebo + Aripiprazole
Drug: Placebo
Placebo qd, 12 days
Drug: Aripiprazole
single dose on day 5
Other Name: Abilify


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00689559

Research Site
Uppsala, Sweden
Sponsors and Collaborators
Study Director: Lennart Jeppsson AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Ctril Clarke, MD ICON Development Solutions UK
  More Information

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje Identifier: NCT00689559     History of Changes
Other Study ID Numbers: D3691C00001
EudraCt nr 2008-000310-74
Study First Received: May 29, 2008
Last Updated: June 30, 2009

Keywords provided by AstraZeneca:
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 21, 2017