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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04175132
• Other study ID #: 18124A
• Status: Terminated
• Phase: Phase 1
• Start date: November 12, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: December 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 10, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Parkinson Disease

Intervention

Drug:
• foliglurax
Capsules of 20/80 mg foliglurax, orally. Single doses of 20-240 mg
• foliglurax
Capsules of 20/80 mg foliglurax, orally. Single doses of 20-160 mg

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	AUC(0-24) foliglurax	Area under the plasma concentration curve from zero to 24 hours	From Day 1 up to Day 3
Secondary	Cmax foliglurax	Maximum observed plasma concentration of foliglurax	From Day 1 up to Day 3
Secondary	Tmax foliglurax	Corresponding time (tmax) in plasma	From Day 1 up to Day 3