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Completed

NCT Number: NCT06004180

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ehime University Hospital

Ehime, 791-0295, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

Lu AF28996

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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