NCT06004180

A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD)

Interventional, Exploratory, Open-label Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Lu AF28996 in Japanese Men and Women With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Lu AF28996	Hard capsule, orally, per schedule specified in the arm description.

Timeline

• Start date: 2023-09-12
• Primary completion: 2023-11-21
• Completion: 2023-11-21
• First posted: 2023-08-22
• Last updated: 2023-12-11

Locations

1 site across 1 country: Japan