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Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)

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: NCT04175132
Recruitment Status : Terminated (New efficacy data from another study)
First Posted : November 22, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
A study to learn how foliglurax binds in regions of the brain

Condition or disease Intervention/treatment Phase
Healthy Parkinson Disease Drug: foliglurax Phase 1

Detailed Description:
To study binding of foliglurax to mGlu4 receptors in human brain, up to 9 healthy subjects (Part A) and up to 8 patients with Parkinson's disease (Part B) will be injected with a liquid dose of a radiolabelled tracer that allows measurement of foliglurax binding in the brain to determine to which degree foliglurax binds to regions of the brain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease
Actual Study Start Date : November 12, 2019
Actual Primary Completion Date : March 3, 2020
Actual Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy subjects Drug: foliglurax
Capsules of 20/80 mg foliglurax, orally. Single doses of 20-240 mg

Experimental: PD patients Drug: foliglurax
Capsules of 20/80 mg foliglurax, orally. Single doses of 20-160 mg




Primary Outcome Measures :
  1. Receptor Occupancy (RO) on the metabotropic glutamate receptor 4 (mGlu4) [ Time Frame: From Day 1 up to Day 3 ]
    in Healthy Participants and in Patients With Parkinson's Disease

  2. C(PET) foliglurax [ Time Frame: From Day 1 up to Day 3 ]
    mean plasma concentration of foliglurax during PET measurement in Healthy Participants and in Patients With Parkinson's Disease


Secondary Outcome Measures :
  1. AUC(0-24) foliglurax [ Time Frame: From Day 1 up to Day 3 ]
    Area under the plasma concentration curve from zero to 24 hours

  2. Cmax foliglurax [ Time Frame: From Day 1 up to Day 3 ]
    Maximum observed plasma concentration of foliglurax

  3. Tmax foliglurax [ Time Frame: From Day 1 up to Day 3 ]
    Corresponding time (tmax) in plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Part A:

  • Healthy subjects
  • The subject has a normal structural MRI (sMRI) scan performed in the screening period, as judged by the investigator.
  • The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
  • The subject can tolerate confined spaces for prolonged periods of time.
  • The subject is suitable for radial and/or brachial artery blood sampling and cannulation.

Part B:

  • Patients with Parkinson's disease
  • The subject has a normal sMRI scan performed in the screening period, as judged by the investigator.
  • The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
  • The patient has been diagnosed with idiopathic Parkinson's disease for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the OFF state.
  • The patient has dyskinesia that is not too severe to cause discomfort for the patient during PET imaging and predictable OFF time
  • In addition to the above criteria, the patient must, in the opinion of the investigator, also be suitable for the study and the included PET imaging sessions.
  • The patient has been receiving a stable regimen of levodopa-containing therapy (total levodopa dose ≤1600 mg per day) (≥3 doses per day of standard levodopa or ≥3 doses per day of carbidopa and levodopa, sustained-release tablets or extended-release capsules of carbidopa and levodopa or benserazide and levodopa), and be on a stable regimen of permitted anti-Parkinsonian drugs (peripheral decarboxylase inhibitors, dopamine agonists [except apomorphine], monoamine oxidase type B [MAO-B] inhibitors [except safinamide], or catechol-O-methyl transferase [COMT] inhibitors) for ≥4 weeks prior to foliglurax dosing
  • The patient can tolerate confined spaces for prolonged periods of time
  • The patient is suitable for radial and/or brachial artery blood sampling and cannulation

Exclusion Criteria:

  • The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP

Other inclusion and exclusion criteria may apply.


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): NCT04175132


Locations
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Sweden
Karolinska Institutet
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: NCT04175132    
Other Study ID Numbers: 18124A
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 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