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HealthyPhase 1NCT04175132

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

A Phase 1 study testing foliglurax in people with Healthy and Parkinson Disease, run by H. Lundbeck A/S at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A study to learn how foliglurax binds in regions of the brain Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Parkinson Disease
What is being tested?
foliglurax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSweden
Study dates
12 Nov 2019to 10 Mar 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Stockholm

Other trials in Sweden

About this study

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

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

Read the 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.

Being tested
foliglurax
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • foligluraxDrug

    Capsules of 20/80 mg foliglurax, orally. Single doses of 20-240 mg

  • foligluraxDrug

    Capsules of 20/80 mg foliglurax, orally. Single doses of 20-160 mg

Study groups in NCT04175132
Study groupRoleWhat they receive
Healthy subjectsExperimentalNot described
Receives: Drug: foliglurax
PD patientsExperimentalNot described
Receives: Drug: foliglurax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Receptor Occupancy (RO) on the metabotropic glutamate receptor 4 (mGlu4)

    in Healthy Participants and in Patients With Parkinson's Disease

    Measured: From Day 1 up to Day 3

  2. C(PET) foliglurax

    mean plasma concentration of foliglurax during PET measurement in Healthy Participants and in Patients With Parkinson's Disease

    Measured: From Day 1 up to Day 3

Secondary outcomes (3)

  1. AUC(0-24) foliglurax

    Area under the plasma concentration curve from zero to 24 hours

    Measured: From Day 1 up to Day 3

  2. Cmax foliglurax

    Maximum observed plasma concentration of foliglurax

    Measured: From Day 1 up to Day 3

  3. Tmax foliglurax

    Corresponding time (tmax) in plasma

    Measured: From Day 1 up to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2019
  2. Study start12 Nov 2019
  3. Primary completion3 Mar 2020
  4. Study completion10 Mar 2020

Why it stopped: New efficacy data from another study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04175132
Sponsor's protocol ID
18124A
Status last verified
Dec 2020
First submitted
12 Nov 2019
Last updated
9 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing foliglurax in people with Healthy and Parkinson Disease, run by H. Lundbeck A/S at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: New efficacy data from another study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receptor Occupancy (RO) on the metabotropic glutamate receptor 4 (mGlu4) (time frame: From Day 1 up to Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04175132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.

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