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Completed

NCT Number: NCT00686413

Positron Emission Tomography Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects

The study is being performed in order to learn more about AZD3480 (potential as treatment for patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as to investigate the period of time for this binding.

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Key information

Conditions

Healthy

Age range

20 year–80 year

Sex eligibility

Male

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
  • Genotyped with regard to CYP2D6
  • Normal MRI scan at Visit 2

Exclusion criteria

  • Known or suspected drug or alcohol abuse or positive drugs of abuse screen as judged by the investigator.
  • Participation in a PET examination as part of a scientific study during the past twelve months.
  • Prescribed or non-prescribed from two weeks prior to the first PET examination. Occasional paracetamol and nasal spray for congestion will be allowed as medication.

Treatment and study plan

AZD3480

Drug

single dose, oral

2-[18F]-F-A85380

Radiation

Single dose, IV

Primary outcomes

  1. Plasma concentration (AUC, Cmax, tmax)

    Time frame: During time period of the PET assessement

  2. The whole brain uptake and regional distribution of radioligand 2-[18F]-F-A85380 following single intravenous (iv) microdose will be assessed (using derived radioactivity measurements).

    Time frame: One on baseline day and one at the drug treatment day

Secondary outcomes

  1. SafetyAEs and vital signs.

    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 Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects (Non Nicotine Users)

Acronym: PET

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 29, 2008
Registry last updated
Dec 10, 2010

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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