Parkinson Disease
Conditions
Brief summary
The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.
Interventions
DRUGLu AF28996
Capsule administered orally per schedule specified in the arm description.
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * The participant is Chinese, defined as having four Chinese grandparents being born in China. * The participant is diagnosed with idiopathic Parkinson's disease (consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD). * The participant's Modified Hoehn and Yahr score is ≥2 and ≤4 (in OFF) and ≤3 in the ON state. * The participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning OFF episodes causing clinically significant disability during the last 3 months prior to screening, as evaluated by the investigator. Key
Exclusion criteria
* The participant has received oral or transdermal dopamine agonist treatment ≤4 weeks prior to screening. * The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation). * The participant has any other disorder for which the treatment takes priority over treatment of Parkinson's disease or is likely to interfere with trial treatment or impair treatment compliance. * The participant has received Traditional Chinese Medicine treatment ≤4 weeks prior to screening. Note: Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 60 days |
| Area Under the Plasma Concentration-time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996 | Days 1, 21 or 31, and 41 |
| Maximum Observed Plasma Concentration (Cmax) of Lu AF28996 | Days 1, 21 or 31, and 41 |
| Time to Reach Cmax (Tmax) of Lu AF28996 | Days 1, 21 or 31, and 41 |
Countries
China
Contacts
CONTACTEmail contact via H. Lundbeck A/S
STUDY_DIRECTOREmail contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Outcome results
None listed