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A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826134
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: [11C]PXT012253 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2019
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [11C]-PXT012253 Drug: [11C]PXT012253
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 Measures :
  1. Total distribution volumes (VT) for each region of interest (ROI) [ Time Frame: Up to 3 days ]
  2. Binding potential (BPND) in the ROI's [ Time Frame: Up to 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826134


Locations
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Sweden
Karolinska Institute, Dept. of Clinical Neuroscience
Stockholm, Sweden
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H.Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03826134    
Other Study ID Numbers: 18039A
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases