Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease

Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: ABBV-951

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital /ID# 229974
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital /ID# 230224
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center /ID# 229983
  • North Carolina
    • Raleigh, North Carolina, United States, 27612-8106
      • Carolina Phase 1, LLC /ID# 239836
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-6378
      • The Movement Disorder Clinic of Oklahoma /ID# 238610
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center /ID# 230255
  • Texas
    • Austin, Texas, United States, 78746
      • Parkinson Disease Movement Disorders Clinic /ID# 245791
    • Georgetown, Texas, United States, 78628-4126
      • Texas Movement Disorder Specialists /ID# 238607
    • Houston, Texas, United States, 77030-3411
      • Baylor College of Medicine - Baylor Medical Center /ID# 239631
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Care /ID# 241219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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: Foslevodopa/foscarbidopa
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: Foslevodopa/foscarbidopa
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: Foslevodopa/foscarbidopa
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: Foslevodopa/foscarbidopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)	Maximum observed plasma concentration (Cmax) of Levodopa (LD).	Up to 8 Days
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD	Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.	Up to 8 Days
Minimum Observed Plasma Concentration (Cmin) of LD	Minimum observed plasma concentration (Cmin) of LD.	Up to 8 Days
Degree of Fluctuation (DFL) of LD	DFL = (Cmax-Cmin)/(average plasma concentration).	Up to 8 Days
Swing of LD	Swing = (Cmax-Cmin)/Cmin.	Up to 8 Days
Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)	Maximum observed plasma concentration (Cmax) of CD.	Up to 8 Days
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD	Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.	Up to 8 Days
Minimum Observed Plasma Concentration (Cmin) of CD	Minimum observed plasma concentration (Cmin) of CD.	Up to 8 Days
Degree of Fluctuation (DFL) of CD	DFL = (Cmax-Cmin)/(average plasma concentration).	Up to 8 Days
Swing of CD	Swing = (Cmax-Cmin)/Cmin.	Up to 8 Days

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's Disease; ABBV-951; Foslevodopa/foscarbidopa; Levodopa (LD); Carbidopa (CD)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: M20-339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No