AZD1390 Administration of a Microdose [11C]AZD1390 to Healthy Volunteers

NCT03215381 | Completed Phase 1

• 1 other identifier: D6940C00001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390 in healthy volunteer males.

Conditions

Healthy Volunteer Male Subjects

Keywords

Healthy Volunteer Male Subjects

Outcome Measures

Primary Outcomes (1)

• Brain distribution of AZD1390

  To assess if 11C AZD1390 crosses the blood brain barrier in healthy volunteers

  up to 2 hours post dose

Study Arms (1)

[11C]AZD1390 Microdose

OTHER

\[11C\]AZD1390 single dose not exceeding 10 ug by IV bolus

Drug: [11C]AZD1390

Interventions

[11C]AZD1390 DRUG

\[11C\]AZD1390

Also known as: Radiolabeled AZD1390

[11C]AZD1390 Microdose

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Karolinska Institutet, Quintiles IMS: collaborator

Study Sites (1)

Research Site

Stockholm, 171 76, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 12, 2017
• Study Start: October 10, 2017
• Primary Completion: February 19, 2018
• Study Completion: February 19, 2018
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)