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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Lu AF28996
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ehime University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lu AF28996

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Area Under the Plasma Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996
Area Under the Plasma Concentration-Time Curve From Zero to 24 Hours Post-Dose (AUC0-24h) of Lu AF28996
Maximum Observed Plasma Concentration (Cmax) of Lu AF28996
Oral Clearance (CL/F) of Lu AF28996

Secondary Outcome Measures

Full Information

First Posted
August 16, 2023
Last Updated
October 11, 2023
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT06004180
Brief Title
A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
November 21, 2023 (Anticipated)
Study Completion Date
November 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lu AF28996
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lu AF28996
Intervention Description
Hard capsule, orally, per schedule specified in the arm description.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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). Note: Other inclusion and exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Email contact via H. Lundbeck A/S
Phone
+45 36301311
Email
LundbeckClinicalTrials@Lundbeck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Ehime University Hospital
City
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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