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

• ClinicalTrials.gov Identifier: NCT05094050
• Recruitment Status: Completed
• First Posted: October 26, 2021
• Last Update Posted: March 24, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: October 20, 2021
• First Posted Date: October 26, 2021
• Last Update Posted Date: March 24, 2023
• Actual Study Start Date: January 18, 2022
• Actual Primary Completion Date: March 17, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2021)

• Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 8 Days ]
  Minimum observed plasma concentration (Cmin) of LD.
• Degree of Fluctuation (DFL) of LD [ Time Frame: Up to 8 Days ]
  DFL = (Cmax-Cmin)/(average plasma concentration).
• Swing of LD [ Time Frame: Up to 8 Days ]
  Swing = (Cmax-Cmin)/Cmin.
• Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 8 Days ]
  Minimum observed plasma concentration (Cmin) of CD.
• Degree of Fluctuation (DFL) of CD [ Time Frame: Up to 8 Days ]
  DFL = (Cmax-Cmin)/(average plasma concentration).
• Swing of CD [ Time Frame: Up to 8 Days ]
  Swing = (Cmax-Cmin)/Cmin.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Parkinson's Disease

Intervention

Drug: ABBV-951

Continuous Subcutaneous Infusion (CSCI)

Other Name: Foslevodopa/foscarbidopa

Study Arms

• 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).
  Intervention: Drug: ABBV-951
• 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).
  Intervention: Drug: ABBV-951
• 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).
  Intervention: Drug: ABBV-951
• 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).
  Intervention: Drug: ABBV-951

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 8, 2023): 16
• Original Estimated Enrollment (submitted: October 20, 2021): 12
• Actual Study Completion Date: March 17, 2023
• Actual Primary Completion Date: March 17, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05094050
• Other Study ID Numbers: M20-339
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: March 2023