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CompletedNCT03826134Updated Feb 5, 2020

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

An Early Phase 1 interventional study of [11C]PXT012253 in Parkinson Disease, sponsored by H. Lundbeck A/S. Completed at 1 site in Sweden. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by H. Lundbeck A/S · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    [11C]-PXT012253

    Drug: [11C]PXT012253

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Karolinska Institute, Dept. of Clinical Neuroscience
    Stockholm, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03826134
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Feb 1, 2019
Start date
Jan 17, 2019
Primary completion
Mar 15, 2019
Completion
Mar 15, 2019
Last update
Feb 5, 2020

Study contacts

Email contact via H.Lundbeck A/S
study director · LundbeckClinicalTrials@Lundbeck.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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