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

AstraZeneca1 site in 1 country11 target enrollmentApril 2009

ConditionsHealthy

Interventions2-[18F]-F-A85380 AZD1446

DrugsAZD1446

Overview

Phase: Phase 1
Intervention: 2-[18F]-F-A85380
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 11
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

August 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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

Arms & Interventions

2-[18F]-F-A85380

Single microdose

Intervention: 2-[18F]-F-A85380

AZD1446

Single oral administration

Intervention: AZD1446

Outcomes

Primary Outcomes

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