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
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Plasma concentration (Cmax, tmax, AUC) [ Time Frame: During time period of the PET assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability (AEs, vital signs, lab) [ Time Frame: During the whole study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00886067     History of Changes
Other Study ID Numbers: D1950C00004, EudraCT No. 2008-008390-55
Study First Received: April 21, 2009
Last Updated: September 9, 2009
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency
Sweden: Radiation Protection Committee

Keywords provided by AstraZeneca:
AZD1446
PET examination

ClinicalTrials.gov processed this record on April 17, 2014