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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686413
First received: May 27, 2008
Last updated: December 8, 2010
Last verified: September 2008

May 27, 2008
December 8, 2010
January 2008
August 2008   (final data collection date for primary outcome measure)
  • Plasma concentration (AUC, Cmax, tmax) [ Time Frame: During time period of the PET assessement ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00686413 on ClinicalTrials.gov Archive Site
SafetyAEs and vital signs. [ Time Frame: During the whole study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: AZD3480
    single dose, oral
  • Radiation: 2-[18F]-F-A85380
    Single dose, IV
  • Experimental: 1
    Intervention: Drug: AZD3480
  • Experimental: 2
    Intervention: Radiation: 2-[18F]-F-A85380
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00686413
D3690C00018, EudraCT No. 2007-004852-35
No
Hans-Göran Hårdemark, MD, PhD, Medical Science Director Clinical Neuroscience TA, AstraZeneca R&D Södertälje
AstraZeneca
Not Provided
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
AstraZeneca
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP