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

Lundbeck

Status and phase

Terminated

Phase 1

Conditions

Healthy

Parkinson Disease

Treatments

Drug: Placebo (treatment C)

Drug: Foliglurax 10 mg (treatment A)

Drug: Foliglurax 30 mg (treatment B)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04322227

18240A

Details and patient eligibility

About

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

Full 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)

Enrollment

6 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Other in- and exclusion criteria may apply