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Positron Emission Tomography (PET) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886067
First Posted: April 22, 2009
Last Update Posted: September 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Healthy Drug: AZD1446 Radiation: 2-[18F]-F-A85380 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]
  • Plasma concentration (Cmax, tmax, AUC) [ Time Frame: During time period of the PET assessment ]

Secondary Outcome Measures:
  • Safety and tolerability (AEs, vital signs, lab) [ Time Frame: During the whole study ]

Enrollment: 11
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2-[18F]-F-A85380
Single microdose
Radiation: 2-[18F]-F-A85380
iv, single dose
Experimental: AZD1446
Single oral administration
Drug: AZD1446
Solution, oral, single dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886067


Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Björn Paulsson, MD, PhD AstraZeneca Södertälje
Principal Investigator: Ingemar , Bylesjö, MD, PhD AstraZeneca CPU Huddinge
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00886067     History of Changes
Other Study ID Numbers: D1950C00004
EudraCT No. 2008-008390-55
First Submitted: April 21, 2009
First Posted: April 22, 2009
Last Update Posted: September 10, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
AZD1446
PET examination