Healthy
Conditions
Keywords
AZD1446, PET examination
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.
Interventions
DRUGAZD1446
Solution, oral, single dose
RADIATION2-[18F]-F-A85380
iv, single dose
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | One PET assessment on baseline day and one PET assessment at the drug treatment day |
| Plasma concentration (Cmax, tmax, AUC) | During time period of the PET assessment |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability (AEs, vital signs, lab) | During the whole study |
Countries
Sweden
Outcome results
None listed