Positron Emission Tomography (PET) Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886067
• Other study ID #: D1950C00004
• Secondary ID: EudraCT No. 2008
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2009
• Last updated: September 9, 2009
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products AgencySweden: Radiation Protection Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD1446
Solution, oral, single dose

Radiation:
• 2-[18F]-F-A85380
iv, single dose

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to a4ß2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at a4ß2 NNRs.		One PET assessment on baseline day and one PET assessment at the drug treatment day	No
Primary	Plasma concentration (Cmax, tmax, AUC)		During time period of the PET assessment	No
Secondary	Safety and tolerability (AEs, vital signs, lab)		During the whole study	No