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To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.
The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients with Parkinson's disease (men and/or women). Each patient will be treated for 3 or 4 days, with increasing dose each day.
Dosing regimen will be decided at a dosing conferences. Dose levels can be increased, maintained or reduced both between cohorts but also within same cohort. The results are presented by dose level and reflect the actual doses administered.
A follow-up safety visit was scheduled approximately 7 days after the last dose of IMP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.04 mg Lu AE04621 | Experimental | Patients having received a dose of 0.04 mg, independent of which Cohort they belong to. |
|
| 0.08 mg Lu AE04621 | Experimental | Patients having received a dose of 0.08 mg, independent of which Cohort they belong to. |
|
| 0.2 mg Lu AE04621 | Experimental | Patients having received a dose of 0.2 mg, independent of which Cohort they belong to. |
|
| 0.4 mg Lu AE04621 | Experimental | Patients having received a dose of 1.2 mg, independent of which Cohort they belong to. |
|
| 0.6 mg Lu AE04621 | Experimental | Patients having received a dose of 0.6 mg, independent of which Cohort they belong to. |
|
| 0.8 mg Lu AE04621 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.04 mg Lu AE04621 | Drug | 0.04 mg dose group |
| |
| 0.08 mg Lu AE04621 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG) | Number of patients with an adverse event | Baseline to day 11 |
| Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621 | From dosing to up to 24 hours after dosing | |
| Maximum Observed Concentration (Cmax) for Lu AE04621 | From dosing to up to 24 hours after dosing | |
| Apparent Elimination Half-life of Lu AE04621 in Plasma (t½) | From dosing to up to 24 hours after dosing | |
| Time to Onset of "ON" Time After Lu AE04621 Administration | "ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'. | From dosing to 90 minutes after dosing |
| Duration of "ON" Time | "ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Outcome measured in minutes. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON' following administration of Lu AE04621. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US1251 | Hallandale | Florida | United States | |||
| US1126 |
Groups are overlapping the cohorts
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Patients received 0.2 mg, 0.4 mg, and 0.6 mg Lu AE04621 on Days 1, 2, and 3, respectively |
| FG001 | Group 2 | Patient received 0.2 mg, 0.4 mg, and 0.2 mg Lu AE04621 on Days 1, 2, and 3, respectively |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients (men and/or women). The dosing regimen planned for Cohort 1 was a dose of 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, and a dose of 0.6 mg Lu AE04621 on Day 3. • The dosing regimen planned for Cohort 2 was 0.4 mg Lu AE04621 on Day 1 followed by a dose of 0.6 mg Lu AE04621 on Day 2, and a dose of 0.8 mg Lu AE04621 on Day 3. The dosing regimen planned for Cohort 3 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.0 mg Lu AE04621 on Day 4. The dosing regimen planned for Cohorts 4 and 5 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.2 mg Lu AE04621 on Day 4. The results are presented by dose groups and are based on the actual doses administered.
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Patients having received a dose of 0.8 mg, independent of which Cohort they belong to. |
|
| 1.0 mg Lu AE04621 | Experimental | Patients having received a dose of 1.0 mg, independent of which Cohort they belong to. |
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| 1.2 mg Lu AE04621 | Experimental | Patients having received a dose of 1.2 mg, independent of which Cohort they belong to. |
|
| Drug |
0.08mg dose group |
|
| 0.2 mg Lu AE04621 | Drug | 0.2 mg dose group |
|
| 0.4 mg Lu AE04621 | Drug | 0.4 mg dose group |
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| 0.6 mg Lu AE04621 | Drug | 0.6 mg dose group |
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| 0.8 mg Lu AE04621 | Drug | 0.8 mg dose group |
|
| 1.0 mg Lu AE04621 | Drug | 1.0 mg dose group |
|
| 1.2 mg Lu AE04621 | Drug | 1.2 mg dose group |
|
| From dosing up to 24h post-dose |
| Orlando |
| Florida |
| United States |
| US1352 | Chicago | Illinois | United States |
| US1084 | Detroit | Michigan | United States |
| FG002 | Group 3 | Patients received 0.4 mg, 0.6 mg, and 0.8 mg Lu AE04621 on Days 1, 2, and 3, respectively |
| FG003 | Group 4 | Patients received 0.2 mg, 0.4 mg, 0.6 mg, and 1.0 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively |
| FG004 | Group 5 | Patients received 0.2 mg, 0.4 mg, 0.6 mg, and 1.2 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively |
| FG005 | Group 6 | Patients received 0.2 mg, 0.4 mg, 0.4 mg, and 0.4 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively |
| FG006 | Group 7 | Patient received 0.04 mg, 0.08 mg, 0.6 mg, and 0.6 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively |
| COMPLETED |
|
| NOT COMPLETED |
|
Total patient population
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| ID | Title | Description |
|---|---|---|
| BG000 | Lu AE04621 | Patients having received 3 or 4 doses of Lu AE04621, ranging from 0.04 to 1.2 mg. Baseline measures are anlayzed on full patient group only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG) | Number of patients with an adverse event | Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of patients having received a particular dose. | Posted | Count of Participants | Participants | Baseline to day 11 |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621 | The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data. The results are reported for the dose groups with sufficient data to calculate the parameter (missing dose groups for AUC(0-24 hours) are: 0.04, 0.08, 0.8, 1.0 and 1.2 mg) | Posted | Mean | Standard Deviation | pgxh/mL | From dosing to up to 24 hours after dosing |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Observed Concentration (Cmax) for Lu AE04621 | Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data. | Posted | Mean | Standard Deviation | pg/mL | From dosing to up to 24 hours after dosing |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Apparent Elimination Half-life of Lu AE04621 in Plasma (t½) | The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data. The results are reported for the dose groups with sufficient data to calculate the parameter (missing dose groups for t½ are: 0.04, 0.08, 0.8, 1.0 and 1.2 mg) | Posted | Mean | Standard Deviation | hour | From dosing to up to 24 hours after dosing |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Onset of "ON" Time After Lu AE04621 Administration | "ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'. | Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'. | Posted | Mean | Standard Deviation | minutes | From dosing to 90 minutes after dosing | dosing occasion when patient turned ON | dosing occasion when patient turned ON |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Duration of "ON" Time | "ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Outcome measured in minutes. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON' following administration of Lu AE04621. | Each patient received 3 or 4 doses of Lu AE04621. The overall number analyzed in each group represents the number of dosing occasion at a particular dose when patients turned 'ON'. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'. | Posted | Mean | Standard Deviation | minutes | From dosing up to 24h post-dose |
|
Baseline to day 11
Treatment-emergent adverse events are reported in this section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.04 mg Lu AE04621 | 0 | 1 | 0 | 1 | 0 | 1 | |
| EG001 | 0.08 mg Lu AE04621 | 0 | 1 | 0 | 1 | 0 | 1 | |
| EG002 | 0.2 mg Lu AE04621 | 0 | 11 | 0 | 11 | 2 | 11 | |
| EG003 | 0.4 mg Lu AE04621 | 0 | 14 | 0 | 14 | 7 | 14 | |
| EG004 | 0.6 mg Lu AE04621 | 0 | 12 | 0 | 12 | 3 | 12 | |
| EG005 | 0.8 mg Lu AE04621 | 0 | 3 | 0 | 3 | 3 | 3 | |
| EG006 | 1 mg Lu AE04621 | 0 | 3 | 0 | 3 | 1 | 3 | |
| EG007 | 1.2 mg Lu AE04621 | 0 | 3 | 0 | 3 | 1 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 19.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | 19.1 | Non-systematic Assessment |
| |
| Chills | General disorders | 19.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | 19.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 19.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 19.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 19.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 19.1 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | 19.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | 19.1 | Non-systematic Assessment |
| |
| Blunted affect | Psychiatric disorders | 19.1 | Non-systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | 19.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 19.1 | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | 19.1 | Non-systematic Assessment |
| |
| Yawning | Respiratory, thoracic and mediastinal disorders | 19.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | 19.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | 19.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 19.1 | Non-systematic Assessment |
|
Because of the limit of quantification, some missing and/or unreliable data prevented the calculation of some of the PK parameters (AUC0-24hours, apparent elimination half-life) for some of the dose groups.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | +45 36301311 | LundbeckClinicalTrials@Lundbeck.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to. |
| OG005 | 0.8 mg Lu AE04621 | Patients having received a dose of 0.8 mg, independent of which Cohort they belong to. |
| OG006 | 1.0 mg Lu AE04621 | Patients having received a dose of 1.0 mg, independent of which Cohort they belong to. |
| OG007 | 1.2 mg Lu AE04621 | Patients having received a dose of 1.2 mg, independent of which Cohort they belong to. |
|
|
|
| OG002 |
| 0.6 mg Lu AE04621 |
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to. |
| OG003 | 0.8 mg Lu AE04621 | Patients having received a dose of 0.8 mg, independent of which Cohort they belong to. |
| OG004 | 1.2 mg Lu AE04621 | Patients having received a dose of 1.2 mg, independent of which Cohort they belong to. |
|
|
| 0.6 mg Lu AE06421 |
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to. |
| OG003 | 0.8 mg Lu AE04621 | Patients having received a dose of 0.8 mg, independent of which Cohort they belong to. |
| OG004 | 1.2 mg Lu AE04621 | Patients having received a dose of 1.2 mg, independent of which Cohort they belong to. |
|
|