Healthy Volunteer Male Subjects Clinical Trial
Official title:
An Open-Label Positron-Emission Tomography (PET) Study to Determine Brain Exposure of AZD1390 After Intravenous Administration of a Microdose [11C]AZD1390 to Healthy Volunteers
| Verified date | February 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390 in healthy volunteer males.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | February 19, 2018 |
| Est. primary completion date | February 19, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 20 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures. - Healthy Male subjects, aged 20 to 65 years (inclusive). - Subject should be healthy as determined by medical history, physical examination, laboratory parameters, ECG and brain MRI performed before administration of the investigational product. - Subject should have a body mass index (BMI) between 18.0 and 30.0 kg/m2 and must weigh at least 50.0 kg and no more than 100.0 kg. - Male subjects must be willing to adhere to true sexual abstinence or use condoms and spermicide (refer to Section 4.3); and refrain from donating sperm during the study and for 3 months plus 5 half-lives after the last administered radiolabelled infusion of [11C]AZD1390. - Subject should be willing and able to participate in all scheduled evaluations, abide by study restrictions, and complete all required tests and procedures. Exclusion criteria: - Known or suspected neurological or behavioural disorders or symptoms that may interfere with the conduct or interpretation of the study, dementia (significant concomitant neurological disease are included under this category). - Current significant major or unstable respiratory, heart, cerebrovascular, haematological, hepatic, renal, gastrointestinal diseases, or other major disease. - Suffers from claustrophobia that limits the ability to undergo the scanning procedure. - Subject has implanted metal devices or implants (MRI contraindications). - Subject has received any concomitant medication or herbal medicine within 2 weeks prior to study drug administration. - Subject has a negative Allen test in both hands at screening, unless brachial artery is used for arterial cannulation. - Use of any anticoagulant within 30 days prior to study drug administration. - Subject has previously participated in a PET imaging study. - Central nervous system infarct, infection or focal lesions of clinical significance on brain MRI scan or abnormalities observed on the brain MRI that would interfere with image analysis - As judged by the investigator, subject with unstable hypertension or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture (orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg). - Presence of significant abnormalities on physical and neurological clinical examinations, vital signs, ECG and clinical chemistry, haematology, or urine analysis results at screening that may interfere with the study or present a safety risk to the study subject. - History or positive results for a systemic infection (e.g. hepatitis B virus, hepatitis C virus, HIV, tuberculosis), including previous or on-going infectious or autoimmune disease at screening. - History of alcohol or drug abuse or dependence (except nicotine) within 1 year prior to screening and/or urine drug screen positive for drug abuse. - Prolonged QTcF >450 ms or family history of long QT syndrome. - History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to [11C]AZD1390. - Judgment by the investigator of any other reason that would prohibit the inclusion of the subject in the study. |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Research Site | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Karolinska Institutet, Quintiles IMS |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brain distribution of AZD1390 | To assess if 11C AZD1390 crosses the blood brain barrier in healthy volunteers | up to 2 hours post dose |