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

Healthy Clinical Trial

— PET  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686413
• Other study ID #: D3690C00018
• Secondary ID: EudraCT No. 2007
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2008
• Last updated: December 8, 2010
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: September 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD3480
single dose, oral

Radiation:
• 2-[18F]-F-A85380
Single dose, IV

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration (AUC, Cmax, tmax)		During time period of the PET assessement	No
Primary	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	No
Secondary	SafetyAEs and vital signs.		During the whole study	Yes