Positron Emission Tomography (PET) Study
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00886067
First received: April 21, 2009
Last updated: September 9, 2009
Last verified: September 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: AZD1446 Radiation: 2-[18F]-F-A85380 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: 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 |
Further study details as provided by AstraZeneca:
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. [ Time Frame: One PET assessment on baseline day and one PET assessment at the drug treatment day ] [ Designated as safety issue: No ]
- Plasma concentration (Cmax, tmax, AUC) [ Time Frame: During time period of the PET assessment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability (AEs, vital signs, lab) [ Time Frame: During the whole study ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | April 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886067
Locations
| Sweden | |
| 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 |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00886067 History of Changes |
| Other Study ID Numbers: | D1950C00004, EudraCT No. 2008-008390-55 |
| Study First Received: | April 21, 2009 |
| Last Updated: | September 9, 2009 |
| Health Authority: | Sweden: Regional Ethical Review Board Sweden: Medical Products Agency Sweden: Radiation Protection Committee |
Keywords provided by AstraZeneca:
|
AZD1446 PET examination |
ClinicalTrials.gov processed this record on May 19, 2013