Positron Emission Tomography (PET) Study

AstraZeneca11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD1446DRUG

Solution, oral, single dose

2-[18F]-F-A85380RADIATION

iv, single dose

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Stockholm, Sweden

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

Secondary Outcomes

Safety and tolerability (AEs, vital signs, lab)

Time frame: During the whole study

Data from ClinicalTrials.gov

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