Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease
Study Details
Study Description
Brief Summary
Parkinson's disease (PD) is a neurological condition, which means it affects the brain. This study will evaluate how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen.
ABBV-951 is an investigational drug being developed for the treatment of PD. Study doctors randomly assign participants to 1 of 4 groups, called treatment arms. Each treatment arm receives ABBV-951 administered in a different order in the arm, high, flank and abdomen. Approximately 12 adult participants over 30 years with a diagnosis of PD will be enrolled in approximately 10 sites in the United States.
Participants will receive continuous (24hours/day) subcutaneous infusion of ABBV-951 for 2 consecutive days for each infusion site (arm, thigh, flank and abdomen), for a total duration of treatment up to 12 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will be confined at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Adverse events will be monitored throughout the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: ABBV-951 Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4). |
Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Names:
|
| Experimental: Arm 2: ABBV-951 Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4). |
Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Names:
|
| Experimental: Arm 3: ABBV-951 Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4). |
Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Names:
|
| Experimental: Arm 4: ABBV-951 Participants will receive ABBV-951 for 2 consecutive days in the flank (Period 1), thigh (Period 2), abdomen (Period 3) and arm (Period 4). |
Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD) [Up to 8 Days]
Maximum observed plasma concentration (Cmax) of Levodopa (LD).
- Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD [Up to 8 Days]
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.
- Minimum Observed Plasma Concentration (Cmin) of LD [Up to 8 Days]
Minimum observed plasma concentration (Cmin) of LD.
- Degree of Fluctuation (DFL) of LD [Up to 8 Days]
DFL = (Cmax-Cmin)/(average plasma concentration).
- Swing of LD [Up to 8 Days]
Swing = (Cmax-Cmin)/Cmin.
- Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD) [Up to 8 Days]
Maximum observed plasma concentration (Cmax) of CD.
- Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD [Up to 8 Days]
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.
- Minimum Observed Plasma Concentration (Cmin) of CD [Up to 8 Days]
Minimum observed plasma concentration (Cmin) of CD.
- Degree of Fluctuation (DFL) of CD [Up to 8 Days]
DFL = (Cmax-Cmin)/(average plasma concentration).
- Swing of CD [Up to 8 Days]
Swing = (Cmax-Cmin)/Cmin.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of idiopathic Parkinson's disease (PD) that is Levodopa-responsive.
-
Must be taking a minimum of 400 mg/day of levodopa equivalents (LE) and be judged by the investigator to have motor symptoms inadequately controlled by current therapy.
-
Must have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum daily average of 2.5 hours of "Off" time (with a minimum of 2 hours of "Off" time each day).
Exclusion Criteria:
- History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Hospital /ID# 229974 | Aurora | Colorado | United States | 80045 |
| 2 | Georgetown University Hospital /ID# 230224 | Washington | District of Columbia | United States | 20007 |
| 3 | Rush University Medical Center /ID# 229983 | Chicago | Illinois | United States | 60612 |
| 4 | M3 Wake Research Inc. /ID# 239836 | Raleigh | North Carolina | United States | 27612-8106 |
| 5 | The Movement Disorder Clinic of Oklahoma /ID# 238610 | Tulsa | Oklahoma | United States | 74136-6378 |
| 6 | Vanderbilt University Medical Center /ID# 230255 | Nashville | Tennessee | United States | 37232-0011 |
| 7 | St. David's Healthcare Partnership, L.P., LLP /ID# 245791 | Austin | Texas | United States | 78701-4082 |
| 8 | Texas Movement Disorder Specialists /ID# 238607 | Georgetown | Texas | United States | 78628-4126 |
| 9 | Baylor College of Medicine - Baylor Medical Center /ID# 239631 | Houston | Texas | United States | 77030-3411 |
| 10 | University of Utah Health Care /ID# 241219 | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M20-339