This trial will evaluate the effects of Lu AF28996 in adult Japanese men and women with Parkinson's disease (PD). The main goals of the trial are to learn more about a) the safety and tolerability of Lu AF28996 (any new or worsening medical issues the participants have with treatment), and b) the pharmacokinetic parameters of Lu AF28996 (how the drug is absorbed, distributed, and processed by the body). Participants will take Lu AF28996 capsules orally once a day (OD). The participants will start with a low dose of Lu AF28996, which will be increased gradually over a period of 2 weeks, and then decreased gradually over a period of about 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Hard capsule, orally, per schedule specified in the arm description.
Ehime University Hospital
Ehime, Japan
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From the day of first dose of study drug (Day 1) up to Day 35
Area Under the Plasma Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996
Time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
Area Under the Plasma Concentration-Time Curve From Zero to 24 Hours Post-Dose (AUC0-24h) of Lu AF28996
Time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
Maximum Observed Plasma Concentration (Cmax) of Lu AF28996
Time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
Oral Clearance (CL/F) of Lu AF28996
Time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
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