Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects

NCT ID: NCT04322227

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2020-05-30

Brief Summary

The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD

Detailed Description

All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either:

• 10 mg foliglurax bis in die (BID) (treatment A)
• 30 mg foliglurax BID (treatment B)
• Placebo BID (treatment C)

Conditions

Parkinson Disease; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Healthy

Group Type: EXPERIMENTAL

Foliglurax 10 mg (treatment A)

Intervention Type: DRUG

Foliglurax 10 mg, (BID) capsules, orally

Foliglurax 30 mg (treatment B)

Intervention Type: DRUG

Foliglurax 30 mg, BID capsules, orally

Placebo (treatment C)

Intervention Type: DRUG

Placebo, BID capsules, orally

PD

Group Type: EXPERIMENTAL

Foliglurax 10 mg (treatment A)

Intervention Type: DRUG

Foliglurax 10 mg, (BID) capsules, orally

Foliglurax 30 mg (treatment B)

Intervention Type: DRUG

Foliglurax 30 mg, BID capsules, orally

Placebo (treatment C)

Intervention Type: DRUG

Placebo, BID capsules, orally

Interventions

Foliglurax 10 mg (treatment A)

Foliglurax 10 mg, (BID) capsules, orally

Intervention Type: DRUG

Foliglurax 30 mg (treatment B)

Foliglurax 30 mg, BID capsules, orally

Intervention Type: DRUG

Placebo (treatment C)

Placebo, BID capsules, orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Healthy subjects

• The subject has an acceptable resting EEG at the Screening Visit, 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.

Patients with PD

• The patient has an acceptable resting EEG performed at 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 PD 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 the EEG assessments

Exclusion Criteria

• The subject has taken disallowed medication <1 week prior to the first dose of Investigational Medicinal Product (IMP) or <5 half-lives prior to the Screening Visit for any medication taken.
• The subject has significant alcohol consumption
• The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP.
• The subjects has a known genetic disorder of human UDPglucoronosyltransferase
• The subject is pregnant or breastfeeding.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Biotrial Rennes

Rennes, , France

Countries

France

Other Identifiers

18240A

Identifier Type: -

Identifier Source: org_study_id