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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
History of Changes
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689559

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

No publications provided

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje
ClinicalTrials.gov 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
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Alzheimer's disease
AZD3480
Aripiprazole

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
 Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013