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

NCT ID: NCT06004180

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2023-11-21

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lu AF28996

Participants will receive ascending oral doses of Lu AF28996 OD for 14 days (Day 1 to Day 14). From Day 15, the participant will initiate down-titration of Lu AF28996 as per investigator's judgement.

Group Type: EXPERIMENTAL

Lu AF28996

Intervention Type: DRUG

Hard capsule, orally, per schedule specified in the arm description.

Interventions

Lu AF28996

Hard capsule, orally, per schedule specified in the arm description.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participant is diagnosed with idiopathic PD (consistent with the United Kingdom Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of Parkinson's Disease) and should not have more than 1 first-degree relative with PD.
• The participant's Modified Hoehn and Yahr score is ≤3 in the ON state and ≤4 in the OFF state.
• The participant experiences well-recognizable and predictable motor fluctuations (≥1.5 hours of OFF-periods in the awake time, predictable morning OFF episodes included) causing clinically significant disability during the 7-week Screening Period.
• The participant currently has a good response to levodopa and has been receiving a stable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitor therapy) ≥4 weeks prior to screening.
• The participant is Japanese, defined as having four Japanese grandparents and being born in Japan.

Exclusion Criteria

• The participant has or had one or more of the following conditions that are considered clinically relevant in the context of the study; other neurological disorder, psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic impairment or renal insufficiency, metabolic disorder, endocrinological disorder, hematological disorder, infectious disorder, any clinically significant immunological condition, or a history of narrow-angle glaucoma.
• The participant has a positive test result for SARS-CoV-2 at the Baseline Visit.
• The participant has undergone a neurosurgical intervention for PD (such as pallidotomy, thalamotomy, fetal or stem cell transplantation or deep brain stimulation).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Ehime University Hospital

Ehime, , Japan

Countries

Japan

Other Identifiers

20399A

Identifier Type: -

Identifier Source: org_study_id