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The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by a continuous subcutaneous infusion in subjects with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-951 Dose 1 | Experimental | Participants will receive dose 1 of ABBV-951. |
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| ABBV-951 Dose 2 | Experimental | Participants will receive dose 2 of ABBV-951. |
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| ABBV-951 Dose 3 | Experimental | Participants will receive dose 3 of ABBV-951. |
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| ABBV-951 Dose 4 | Experimental | Participants will receive dose 4 of ABBV-951. |
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| ABBV-951 Dose 5 | Experimental | Participants will receive dose 5 of ABBV-951. |
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| ABBV-951 Dose 6 | Experimental | Participants will receive dose 6 of ABBV-951. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-951 | Drug | ABBV-951 administered by subcutaneous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Levodopa | Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951. | Hour 0-24 |
| Time to maximum observed plasma concentration (Tmax) of Levodopa | Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951. | Hour 0-24 |
| Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa | Area under the plasma concentration-time curve following a single infusion of ABBV-951. | Hour 0-24 |
| Adverse Events | Number of participants reporting adverse events | 24 hours |
| Terminal phase elimination rate constant (β) | Apparent terminal phase elimination rate constant (β or Beta) | Up to 72 hours |
| Terminal phase elimination half-life (T1/2) | Terminal phase elimination half-life (t1/2) will be assessed. | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected QT (QTc) Interval | QT interval adjusted for heart rate. | Up to 76 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Adventist Medical Ctr /ID# 166512 | Glendale | California | 91206 | United States | ||
| Bioclinica Research - Orlando /ID# 169687 |
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| ABBV-951 Dose 7 | Experimental | Participants will receive dose 7 of ABBV-951. |
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| ABBV-951 Dose 8 | Experimental | Participants will receive dose 8 of ABBV-951. |
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| Orlando |
| Florida |
| 32806 |
| United States |
| Acpru /Id# 154976 | Grayslake | Illinois | 60030 | United States |
| University of Kentucky Chandler Medical Center /ID# 169086 | Lexington | Kentucky | 40536 | United States |
| Parexel Baltimore /ID# 169255 | Baltimore | Maryland | 21225 | United States |
| QUEST Research Institute /ID# 166035 | Farmington Hills | Michigan | 48334-2977 | United States |
| Carolina Phase I, LLC /ID# 166034 | Raleigh | North Carolina | 27612 | United States |
| 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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