Parkinson DiseasePhase 1NCT06004180
A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD)
A Phase 1 study testing Lu AF28996 in people with Parkinson Disease, run by H. Lundbeck A/S at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Lu AF28996
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 12 Sep 2023to 21 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Lu AF28996
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF28996Drug
Hard capsule, orally, per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Lu AF28996 | Experimental | 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. Receives: Drug: Lu AF28996 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From the day of first dose of study drug (Day 1) up to Day 35
Area Under the Plasma Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996
Measured: 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
Area Under the Plasma Concentration-Time Curve From Zero to 24 Hours Post-Dose (AUC0-24h) of Lu AF28996
Measured: 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
Maximum Observed Plasma Concentration (Cmax) of Lu AF28996
Measured: 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
Oral Clearance (CL/F) of Lu AF28996
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start12 Sep 2023
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004180
- Sponsor's protocol ID
- 20399A
- Status last verified
- Dec 2023
- First submitted
- 16 Aug 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06004180
- Acronym / sponsor ID
- 20399A
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AF28996 | Experimental | Drug: Lu AF28996Participants 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF28996Hard capsule, orally, per schedule specified in the arm description. | Drug | Lu AF28996 |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AF28996 in people with Parkinson Disease, run by H. Lundbeck A/S at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.