Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF82422 | Experimental | Part A: Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women) Part B: Cohort B1, B2, B3: 24 patients with Parkinson's disease |
|
| Placebo | Placebo Comparator | Part A: Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women) Part B: Cohort B1, B2, B3: 24 patients with Parkinson's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF82422 | Drug | Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters) | From dosing to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-t | Area under the Lu AF82422 plasma concentration curve from zero to time t | From dosing to Day 84 |
| Cmax | Maximum observed plasma concentration of Lu AF82422 |
Not provided
Inclusion criteria:
Healthy subjects:
- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)
Patients with Parkinson's disease:
Exclusion criteria:
Other in- and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group (CCTMG) | Glendale | California | 91206 | United States | ||
| Reserach Center of America |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Cohort
Not provided
Not provided
Not provided
| Placebo | Drug | placebo - concentrate for solution for infusion, single dose |
|
| From dosing to Day 84 |
| CL | Clearance of Lu AF82422 | From dosing to Day 84 |
| Hollywood |
| Florida |
| 33024 |
| United States |
| PPD | Orlando | Florida | 32806 | United States |
| Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital | Baltimore | Maryland | 21225 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |