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Positron Emission Tomography (PET) Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00886067
First received: April 21, 2009
Last updated: September 9, 2009
Last verified: September 2009
History of Changes

April 21, 2009
September 9, 2009
April 2009
August 2009   (final data collection date for primary outcome measure)
  • Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs. [ Time Frame: One PET assessment on baseline day and one PET assessment at the drug treatment day ] [ Designated as safety issue: No ]
  • Plasma concentration (Cmax, tmax, AUC) [ Time Frame: During time period of the PET assessment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00886067 on ClinicalTrials.gov Archive Site
Safety and tolerability (AEs, vital signs, lab) [ Time Frame: During the whole study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography (PET) Study
An Open-label Positron Emission Tomography (PET) Study Using 2 [18F] F A85380 to Determine α4β2 Neuronal Nicotinic Receptor (NNR) Occupancy of AZD1446 After Oral Administration to Male and Non-fertile Female (Non-nicotine Users) Healthy Volunteers

The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: AZD1446
    Solution, oral, single dose
  • Radiation: 2-[18F]-F-A85380
    iv, single dose
  • Experimental: 2-[18F]-F-A85380
    Single microdose
    Intervention: Radiation: 2-[18F]-F-A85380
  • Experimental: AZD1446
    Single oral administration
    Intervention: Drug: AZD1446
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Physically healthy volunteers
  • Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • History of severe allergy/hypersensitivity reactions
  • Participation in a PET examination as part of a scientific study during the past twelve months
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00886067
D1950C00004, EudraCT No. 2008-008390-55
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Björn Paulsson, MD, PhD AstraZeneca Södertälje
Principal Investigator: Ingemar , Bylesjö, MD, PhD AstraZeneca CPU Huddinge
AstraZeneca
September 2009

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