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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00686413

Acronym

PET

Enrollment

Registered

2008-05-29

Start date

2008-01-31

Completion date

2008-08-31

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PET, AZD3480, PET examination

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.

Interventions

DRUGAZD3480

single dose, oral

RADIATION2-[18F]-F-A85380

Single dose, IV

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
SafetyAEs and vital signs.	During the whole study

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026