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Completed

NCT Number: NCT00886067

Positron Emission Tomography (PET) Study

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1446

Drug

Solution, oral, single dose

2-[18F]-F-A85380

Radiation

iv, single dose

Primary outcomes

  1. 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

  2. Plasma concentration (Cmax, tmax, AUC)

    Time frame: During time period of the PET assessment

Secondary outcomes

  1. Safety and tolerability (AEs, vital signs, lab)

    Time frame: During the whole study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2009
Registry last updated
Sep 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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