PET: Positron Emission Tomography Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00686413

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD3480 Radiation: 2-[18F]-F-A85380	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label Positron Emission Tomography (PET) Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects (Non Nicotine Users)

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD3480 single dose, oral
Experimental: 2	Radiation: 2-[18F]-F-A85380 Single dose, IV

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD3480

single dose, oral

Experimental: 2

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

Single dose, IV

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

SafetyAEs and vital signs. [During the whole study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Stockholm		Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Hans-Göran, Hårdemark, MD, PhD, Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Bo Fransson, MD, AstraZeneca Clinical Pharmacology Unit, C2-84, Karolinska University Hospital Huddinge, Stockholm, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00686413

Other Study ID Numbers:

D3690C00018
EudraCT No. 2007-004852-35

First Posted:

May 29, 2008

Last Update Posted:

Dec 10, 2010

Last Verified:

Sep 1, 2008

Keywords provided by , ,

PET

AZD3480

PET examination

Study Results

No Results Posted as of Dec 10, 2010