Brain Distribution of [11C]AZ12807110 and AZD5213 Clinical Trial
Official title:
An Open-label Positron Emission Tomography Study to Evaluate Use of Histamine H3 Receptor Radioligand [11C]AZ12807110 and to Determine Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration to Healthy Volunteers
| Verified date | January 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Healthy male and/or female volunteers between 20 to 45 years with suitable veins for cannulation or repeated venipuncture (pilot panel) - Female must be of non-child bearing potential (pilot panel) - BMI between 18 to 30 30 kg/m2 - Normal MRI scan - Provision of signed, written and dated informed consent Exclusion Criteria: - History of any clinically significant disease or disorder - History or presence of gastrointestinal, hepatic or renal disease - Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome - History of severe allergy or hypersensitivity or ongoing allergy or hypersensitivity - Healthy volunteer suffers from claustrophobia |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Research Site | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Distribution volume (VT) | Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. Single PET measurement will take maximum 2 hours. | No | |
| Primary | Estimation of the plasma concentration resulting in 50% receptor occupancy (Ki, pl). | Each healthy volunteer in the main panel will complete 3 PET measurements using radioligand; one at baseline and 2 after treatment with AZD5213. | Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. | No |
| Secondary | Adverse events | Collected from Day 1 to follow-up | Yes | |
| Secondary | Vital signs (body temperature, BP and pulse) | Measured at screening, study days -1 to day 3 and at follow-up | Yes |