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 (PET)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686413
First received: May 27, 2008
Last updated: December 8, 2010
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AZD3480
Radiation: 2-[18F]-F-A85380
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Plasma concentration (AUC, Cmax, tmax) [ Time Frame: During time period of the PET assessement ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SafetyAEs and vital signs. [ Time Frame: During the whole study ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD3480
single dose, oral
Experimental: 2 Radiation: 2-[18F]-F-A85380
Single dose, IV

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686413

Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans-Göran , Hårdemark, MD, PhD Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Bo Fransson, MD AstraZeneca Clinical Pharmacology Unit, C2-84, Karolinska University Hospital Huddinge, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director Clinical Neuroscience TA, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier: NCT00686413     History of Changes
Other Study ID Numbers: D3690C00018, EudraCT No. 2007-004852-35
Study First Received: May 27, 2008
Last Updated: December 8, 2010
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
PET
AZD3480
PET examination

ClinicalTrials.gov processed this record on October 23, 2014