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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD3480; Radiation: 2-[18F]-F-A85380

• Registration Number: NCT00686413
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2008-09
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD3480	-
2	2-[18F]-F-A85380	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
SafetyAEs and vital signs.	During the whole study

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden