NCT00689559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 2, 2009

Status Verified

June 1, 2009

First QC Date

May 29, 2008

Last Update Submit

June 30, 2009

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseaseAZD3480Aripiprazole

Outcome Measures

Primary Outcomes (1)

  • PK variables

    Frequent sampling occasions during

Secondary Outcomes (1)

  • Safety variables (adverse events, blood pressure, pulse, safety lab)

    During the whole treatment period

Study Arms (2)

1

EXPERIMENTAL

AZD3480 + Aripiprazole

Drug: AZD3480Drug: Aripiprazole

2

EXPERIMENTAL

Placebo + Aripiprazole

Drug: PlaceboDrug: Aripiprazole

Interventions

AZD3480DRUG

AZD3480 capsules qd, oral, 22 days

1
PlaceboDRUG

Placebo qd, 12 days

2
AripiprazoleDRUG

single dose on day 5

Also known as: Abilify
12

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed written informed consent
  • Clinically normal physical findings and laboratory values

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

isproniclineAripiprazole

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lennart Jeppsson

    AstraZeneca R&D, Södertälje, Sweden

    STUDY DIRECTOR

  • Ctril Clarke, MD

    ICON Development Solutions UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 3, 2008

Study Start

March 1, 2008

Study Completion

April 1, 2009

Last Updated

July 2, 2009

Record last verified: 2009-06

Locations

SE(1)