Clinical trial NCT05094050: Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease
Official title: Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Foslevodopa/foscarbidopa
ABBV-951
Levodopa (LD)
Carbidopa (CD)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)
timeFrame: Up to 8 Days
measure: Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD
timeFrame: Up to 8 Days
measure: Minimum Observed Plasma Concentration (Cmin) of LD
timeFrame: Up to 8 Days
measure: Degree of Fluctuation (DFL) of LD
timeFrame: Up to 8 Days
measure: Swing of LD
timeFrame: Up to 8 Days
measure: Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)
timeFrame: Up to 8 Days
measure: Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD
timeFrame: Up to 8 Days
measure: Minimum Observed Plasma Concentration (Cmin) of CD
timeFrame: Up to 8 Days
measure: Degree of Fluctuation (DFL) of CD
timeFrame: Up to 8 Days
measure: Swing of CD
timeFrame: Up to 8 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital /ID# 229974
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital /ID# 230224
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center /ID# 229983
state: Illinois
city: Raleigh
country: United States
facility: Carolina Phase 1, LLC /ID# 239836
state: North Carolina
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma /ID# 238610
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 230255
state: Tennessee
city: Austin
country: United States
facility: Parkinson Disease Movement Disorders Clinic /ID# 245791
state: Texas
city: Georgetown
country: United States
facility: Texas Movement Disorder Specialists /ID# 238607
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Medical Center /ID# 239631
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Care /ID# 241219
state: Utah
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: