NCT04291859

Lu AF28996 in Participants With Parkinson's Disease (PD)

Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of different parts. Part A of the study will consist of once daily (OD) cohorts (OD Cohort 1 to 3), as well as twice daily (BID) cohorts (BID Cohorts A1 and A2). Part B will consist of 3 cohorts (Cohorts B1, B2, and B3) whereby participants will be administered Lu AF28996 BID.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Lu AF28996	capsule, orally, doses and dose escalation scheme will be decided upon at dosing conferences

Timeline

• Start date: 2020-02-26
• Primary completion: 2025-10-14
• Completion: 2026-02-12
• First posted: 2020-03-02
• Last updated: 2026-03-06

Locations

15 sites across 5 countries: United States, France, Germany, Netherlands, Spain

Regulatory

• FDA-regulated drug study