Positron Emission Tomography (PET) Study
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00886067
Collaborator
(none)
11
1
2
4
2.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
11 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Study Start Date
:
Apr 1, 2009
Actual Primary Completion Date
:
Aug 1, 2009
Actual Study Completion Date
:
Aug 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 2-[18F]-F-A85380 Single microdose |
Radiation: 2-[18F]-F-A85380
iv, single dose
|
| Experimental: AZD1446 Single oral administration |
Drug: AZD1446
Solution, oral, single dose
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Safety and tolerability (AEs, vital signs, lab) [During the whole study]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Stockholm | Sweden |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Björn Paulsson, MD, PhD, AstraZeneca Södertälje
- Principal Investigator: Ingemar, Bylesjö, MD, PhD, AstraZeneca CPU Huddinge
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00886067
Other Study ID Numbers:
- D1950C00004
- EudraCT No. 2008-008390-55
First Posted:
Apr 22, 2009
Last Update Posted:
Sep 10, 2009
Last Verified:
Sep 1, 2009