NCT00686413

Brief Summary

The study is being performed in order to learn more about AZD3480 (potential as treatment for patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as to investigate the period of time for this binding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2008

Typical duration for phase_1 healthy

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

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 10, 2010

Status Verified

September 1, 2008

Enrollment Period

7 months

First QC Date

May 27, 2008

Last Update Submit

December 8, 2010

Conditions

Healthy

Keywords

PETAZD3480PET examination

Outcome Measures

Primary Outcomes (2)

  • Plasma concentration (AUC, Cmax, tmax)

    During time period of the PET assessement

  • The whole brain uptake and regional distribution of radioligand 2-[18F]-F-A85380 following single intravenous (iv) microdose will be assessed (using derived radioactivity measurements).

    One on baseline day and one at the drug treatment day

Secondary Outcomes (1)

  • SafetyAEs and vital signs.

    During the whole study

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD3480

2

EXPERIMENTAL
Radiation: 2-[18F]-F-A85380

Interventions

AZD3480DRUG

single dose, oral

1
2-[18F]-F-A85380RADIATION

Single dose, IV

2

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physically Healthy volunteers
  • Genotyped with regard to CYP2D6
  • Normal MRI scan at Visit 2

You may not qualify if:

  • Known or suspected drug or alcohol abuse or positive drugs of abuse screen as judged by the investigator.
  • Participation in a PET examination as part of a scientific study during the past twelve months.
  • Prescribed or non-prescribed from two weeks prior to the first PET examination. Occasional paracetamol and nasal spray for congestion will be allowed as medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Interventions

ispronicline2-fluoro-3-(2-azetidinylmethoxy)pyridine

Study Officials

  • Hans-Göran, Hårdemark, MD, PhD

    Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden

    STUDY DIRECTOR

  • Bo Fransson, MD

    AstraZeneca Clinical Pharmacology Unit, C2-84, Karolinska University Hospital Huddinge, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 10, 2010

Record last verified: 2008-09

Locations

SE(1)