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| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
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An Open-Label Study in Healthy Male and Female Subjects to Identify the Concentration that Provides Optimal Bioavailability of Levodopa Infused Subcutaneously via a Pump System; and to Compare the Bioavailability of Levodopa/Carbidopa Solution to that of Levodopa/Carbidopa Intestinal Gel (LCIG), Infused via a Naso-Jejunal Tube
Part 1: This is a single centre, open-label design with 2 study arms (ND0612H and ND0612L), in 24 subjects that will receive the ND0612L or ND0612H regimens. Part of the subjects will also participate in Part 2 of the study. Within each study arm, subjects will receive 3 doses of the investigational LD/CD solution for subcutaneous (SC) infusion. Study drug will be administered for 24 -30 hours as a subcutaneous (SC) infusion to the lower abdomen. Then subjects will be readmitted for Part 2. Part 2: This is a single centre, open-label design with 3 treatment arms to which 15 subjects who completed the ND0612H arm of Part 1 ND0612-005a will be allocated in a randomised manner. Within each treatment arm subjects will receive 2 out of 3 doses of LCIG infused for 16 hours directly to the jejunum. Subjects will be discharged from the clinic 24 hours after the end of the last infusion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ND0612L (LD/CD solution) | Experimental | 3 doses of the investigational ND0612L (LD/CD solution) for subcutaneous (SC) infusion 0.24ml per hour. |
|
| ND0612H (LD/CD solution) | Experimental | 3 doses of the investigational ND0612H (LD/CD solution) for subcutaneous (SC) infusion 0.64ml per hour. |
|
| LCIG (Levodopa-carbidopa intestinal gel) | Active Comparator | Active Comparator: LCIG subjects who completed the ND0612H arm will be administered with 3 doses of LCIG, directly to the jejunum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND0612 | Drug | Subcutaneous solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximal plasma concentration) of CD for different doses of CD | Pre-infusion and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 20, 22, 24, 25, 26, 27, 28, 29, 30, 31, and 32 hours after commencing the ND0612 infusion on Days 1, 3 and 5. | 6 days |
| AUC (area under the curve) of CD for different doses of CD | Pre-infusion and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 20, 22, 24, 25, 26, 27, 28, 29, 30, 31, and 32 hours after commencing the ND0612 infusion on Days 1, 3 and 5. | 6 days |
| Cmax (maximal plasma concentration) of LD and CD for ND0612 vs. LCIG | Pre-infusion and at 1, 2, 3, 4, 6, 9, 12, 14, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after commencing the LCIG infusion on Days 1 and 3. | 4 days |
| AUC (area under the curve) of LD and CD for ND0612. LCIG | Pre-infusion and at 1, 2, 3, 4, 6, 9, 12, 14, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after commencing the LCIG infusion on Days 1 and 3. | 4 days |
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Inclusion Criteria:
Inclusion Criteria: Part 1 ND0612-005a:
Inclusion Criteria: Part 2 ND0612-005b:
1. Subjects who were dosed with ND0612H (any replacements subjects enrolled in Part 2 will be dosed with the optimal LD/CD concentration of ND0612H after completion of Part 2).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip evans, MBChB, MRCS | Quotient Clinical LTD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical LTD | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| LCIG | Drug | Intrajejunal Gel |
|
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |