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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 (PET)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 27, 2008
Last updated: December 8, 2010
Last verified: September 2008
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 Intervention Phase
Drug: AZD3480
Radiation: 2-[18F]-F-A85380
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Plasma concentration (AUC, Cmax, tmax) [ Time Frame: 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). [ Time Frame: One on baseline day and one at the drug treatment day ]

Secondary Outcome Measures:
  • SafetyAEs and vital signs. [ Time Frame: During the whole study ]

Enrollment: 9
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD3480
single dose, oral
Experimental: 2 Radiation: 2-[18F]-F-A85380
Single dose, IV


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00686413

Research Site
Stockholm, Sweden
Sponsors and Collaborators
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
  More Information

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director Clinical Neuroscience TA, AstraZeneca R&D Södertälje Identifier: NCT00686413     History of Changes
Other Study ID Numbers: D3690C00018
EudraCT No. 2007-004852-35
Study First Received: May 27, 2008
Last Updated: December 8, 2010

Keywords provided by AstraZeneca:
PET examination processed this record on April 28, 2017