Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004180
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2023-08-16
Brief Title:
A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinsons Disease PD
Sponsor:
H Lundbeck AS
Organization:
H Lundbeck AS
Study Overview
Official Title:
Interventional Exploratory Open-label Trial Investigating the Safety Tolerability Pharmacokinetics and Pharmacodynamic Properties of Lu AF28996 in Japanese Men and Women With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will evaluate the effects of Lu AF28996 in adult Japanese men and women with Parkinsons 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None