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Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00689559
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : July 2, 2009
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: AZD3480 Drug: Placebo Drug: Aripiprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
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)
Study Start Date : March 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689559


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

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Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier: NCT00689559    
Other Study ID Numbers: D3691C00001
EudraCt nr 2008-000310-74
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009
Keywords provided by AstraZeneca:
Alzheimer's disease
AZD3480
Aripiprazole
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists