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

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

Sponsors

Lead Sponsor: H. Lundbeck A/S

Source H. Lundbeck A/S
Brief Summary

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

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.

Overall Status Terminated
Start Date November 12, 2019
Completion Date March 3, 2020
Primary Completion Date March 3, 2020
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Receptor Occupancy (RO) on the metabotropic glutamate receptor 4 (mGlu4) From Day 1 up to Day 3
C(PET) foliglurax From Day 1 up to Day 3
Secondary Outcome
Measure Time Frame
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
Enrollment 6
Condition
Intervention

Intervention Type: Drug

Intervention Name: foliglurax

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

Arm Group Label: Healthy subjects

Intervention Type: Drug

Intervention Name: foliglurax

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

Arm Group Label: PD patients

Eligibility

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.

Gender: All

Minimum Age: 50 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Email contact via H. Lundbeck A/S Study Director [email protected]
Location
Facility: Karolinska Institutet
Location Countries

Sweden

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Healthy subjects

Type: Experimental

Label: PD patients

Type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov