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

NCT04175132 | Terminated Phase 1

• 1 other identifier: 18124A
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Parkinson Disease

Outcome Measures

Primary Outcomes (2)

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

  in Healthy Participants and in Patients With Parkinson's Disease

  From Day 1 up to Day 3

• C(PET) foliglurax

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

  From Day 1 up to Day 3

Secondary Outcomes (3)

• AUC(0-24) foliglurax

  From Day 1 up to Day 3

• Cmax foliglurax

  From Day 1 up to Day 3

• Tmax foliglurax

  From Day 1 up to Day 3

Study Arms (2)

Healthy subjects

EXPERIMENTAL

Drug: foliglurax

PD patients

EXPERIMENTAL

Drug: foliglurax

Interventions

foliglurax DRUG

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

Healthy subjects

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

foliglurax

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 22, 2019
• Study Start: November 12, 2019
• Primary Completion: March 3, 2020
• Study Completion: March 10, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

SE (1)