Validation of the novel PET tracer [18F]PK209 in healthy volunteers: Dosimetry, test-retest, and specific binding to the NMDA receptor

Completed

• Conditions: onderzoek heeft in de toekomst betrekking op bovenstaande aandoeningen, maar wordt uitgevoerd bij gezonde controles; there is no disease; 10029305; 10039628

• Registration Number: NL-OMON40871
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure.
2. Healthy male and female subjects, 18 to 70 years of age (inclusive). Healthy status is defined by absence of evidence of any active or chronic disease following a physical examination by a trained physician (assistant), and no clinically significant abnormal results in haematology, blood chemistry, and urinalysis.
3. Body mass index (BMI) between 18 and 34 kg/m2 (inclusive), and with a minimum weight of 50 kg.
4. Able to communicate well with the investigator in the Dutch language and able to comply with the study restrictions.
5. Able to lie comfortably in the PET scanner for a period of two hours.

Exclusion Criteria

1. Any known factor, condition, or disease that might interfere with study compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
2. Positive test for drugs of abuse at screening or pre-PET.
3. Intake of an investigational medicinal product within 30 days prior to the start of this study.
4. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
5. Any condition that may interfere with MRI scanning, e.g. metal objects in or around the body or claustrophobia
6. Pregnant (as tested within 24 hours of the PET scan) or breastfeeding.
7. Inclusion in a research protocol in the past 3 years involving ionizing radiation, which would result in exceeding the ICRP category IIb limit of 10 mSv in addition to natural background radiation.
8. Unacceptable non-pharmacological substances or concomitant medications at baseline. Especially drugs that extend the QT-interval, or (only for cohort 3) drugs that may interact with ketamine (inhibitors of CYP2B6, CYP2C9, CYP3A4) or any other drugs known or likely to affect with study assessments.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) To assess the whole body biodistribution and dosimetry of [18F]PK209<br /><br>2) To examine the regional brain uptake, metabolites, and test-retest<br /><br>variability of [18F]PK209<br /><br>3) To examine the specific binding potential of [18F]PK209 in the brain before<br /><br>and after ketamine displacement</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>