A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
[11C]PXT012253
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects age 20-50 inclusive
- Body mass index (BMI) between 19 and 30 kg/m2
- Normal sMRI scan, performed within 3 months, as judged by the investigator
- The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
- Women of childbearing potential and men whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter
- A propensity to tolerate confined spaces for prolonged periods
- Suitability for radial and/or brachial artery blood sampling and cannulation
Exclusion Criteria:
- History of clinically significant cardio-or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator
- The subject has 1 or more clinical laboratory test values outside the reference range, which in the opinion of the investigator are clinically significant
- Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility
- The subject has a resting pulse <=50 or >=100 bpm at the Screening Visit
- The subject has a QTc interval >430 ms (Bazett's or Fridericia's correction) at the Screening Visit or at he Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator. The ECG may be repeated if any of the values are out-of-range or abnormal
- The subject is pregnant or breastfeeding
- Habitual use of nicotine products and addictive substances
- Any finding of significance on MRI scans as judged by the investigator.
- Any previous PET measurements for scientific purposes
- Use of CNS active drugs and/or NSAIDs 1 month prior to the first PET examination
- The subject is exposed to significant level of ionizing radiation at work
- The subject has undergone any clinical procedures involving significant exposure to radiation (excluding dental X-ray and common X-rays of the chest or extremities)
- The subject has received radio labeled material less than 12
Sites / Locations
- Karolinska Institute, Dept. of Clinical Neuroscience
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[11C]-PXT012253
Arm Description
Outcomes
Primary Outcome Measures
Total distribution volumes (VT) for each region of interest (ROI)
Binding potential (BPND) in the ROI's
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03826134
Brief Title
A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects
Official Title
Interventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the usefulness of a PET radioligand to estimate the binding on the mGlu4 receptor in the brain. mGlu4 has been proposed as a therapeutic target in Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[11C]-PXT012253
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[11C]PXT012253
Intervention Description
Single intravenous bolus injection. The injected amount will be less than 5 μg. The radioactive dose is approximately 400 MBq per 70 kg body weight.
Primary Outcome Measure Information:
Title
Total distribution volumes (VT) for each region of interest (ROI)
Time Frame
Up to 3 days
Title
Binding potential (BPND) in the ROI's
Time Frame
Up to 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects age 20-50 inclusive
Body mass index (BMI) between 19 and 30 kg/m2
Normal sMRI scan, performed within 3 months, as judged by the investigator
The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
Women of childbearing potential and men whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter
A propensity to tolerate confined spaces for prolonged periods
Suitability for radial and/or brachial artery blood sampling and cannulation
Exclusion Criteria:
History of clinically significant cardio-or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator
The subject has 1 or more clinical laboratory test values outside the reference range, which in the opinion of the investigator are clinically significant
Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility
The subject has a resting pulse <=50 or >=100 bpm at the Screening Visit
The subject has a QTc interval >430 ms (Bazett's or Fridericia's correction) at the Screening Visit or at he Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator. The ECG may be repeated if any of the values are out-of-range or abnormal
The subject is pregnant or breastfeeding
Habitual use of nicotine products and addictive substances
Any finding of significance on MRI scans as judged by the investigator.
Any previous PET measurements for scientific purposes
Use of CNS active drugs and/or NSAIDs 1 month prior to the first PET examination
The subject is exposed to significant level of ionizing radiation at work
The subject has undergone any clinical procedures involving significant exposure to radiation (excluding dental X-ray and common X-rays of the chest or extremities)
The subject has received radio labeled material less than 12
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H.Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska Institute, Dept. of Clinical Neuroscience
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects
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