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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABBV-951
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Foslevodopa/foscarbidopa, ABBV-951, Levodopa (LD), Carbidopa (CD)

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Hospital /ID# 229974
  • Georgetown University Hospital /ID# 230224
  • Rush University Medical Center /ID# 229983
  • Carolina Phase 1, LLC /ID# 239836
  • The Movement Disorder Clinic of Oklahoma /ID# 238610
  • Vanderbilt University Medical Center /ID# 230255
  • Parkinson Disease Movement Disorders Clinic /ID# 245791
  • Texas Movement Disorder Specialists /ID# 238607
  • Baylor College of Medicine - Baylor Medical Center /ID# 239631
  • University of Utah Health Care /ID# 241219

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: ABBV-951

Arm 2: ABBV-951

Arm 3: ABBV-951

Arm 4: ABBV-951

Arm Description

Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4).

Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4).

Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4).

Participants will receive ABBV-951 for 2 consecutive days in the flank (Period 1), thigh (Period 2), abdomen (Period 3) and arm (Period 4).

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)
Maximum observed plasma concentration (Cmax) of Levodopa (LD).
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.
Minimum Observed Plasma Concentration (Cmin) of LD
Minimum observed plasma concentration (Cmin) of LD.
Degree of Fluctuation (DFL) of LD
DFL = (Cmax-Cmin)/(average plasma concentration).
Swing of LD
Swing = (Cmax-Cmin)/Cmin.
Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)
Maximum observed plasma concentration (Cmax) of CD.
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.
Minimum Observed Plasma Concentration (Cmin) of CD
Minimum observed plasma concentration (Cmin) of CD.
Degree of Fluctuation (DFL) of CD
DFL = (Cmax-Cmin)/(average plasma concentration).
Swing of CD
Swing = (Cmax-Cmin)/Cmin.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2021
Last Updated
March 22, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05094050
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
March 17, 2023 (Actual)
Study Completion Date
March 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Foslevodopa/foscarbidopa, ABBV-951, Levodopa (LD), Carbidopa (CD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: ABBV-951
Arm Type
Experimental
Arm Description
Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4).
Arm Title
Arm 2: ABBV-951
Arm Type
Experimental
Arm Description
Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4).
Arm Title
Arm 3: ABBV-951
Arm Type
Experimental
Arm Description
Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4).
Arm Title
Arm 4: ABBV-951
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
ABBV-951
Other Intervention Name(s)
Foslevodopa/foscarbidopa
Intervention Description
Continuous Subcutaneous Infusion (CSCI)
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)
Description
Maximum observed plasma concentration (Cmax) of Levodopa (LD).
Time Frame
Up to 8 Days
Title
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD
Description
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.
Time Frame
Up to 8 Days
Title
Minimum Observed Plasma Concentration (Cmin) of LD
Description
Minimum observed plasma concentration (Cmin) of LD.
Time Frame
Up to 8 Days
Title
Degree of Fluctuation (DFL) of LD
Description
DFL = (Cmax-Cmin)/(average plasma concentration).
Time Frame
Up to 8 Days
Title
Swing of LD
Description
Swing = (Cmax-Cmin)/Cmin.
Time Frame
Up to 8 Days
Title
Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)
Description
Maximum observed plasma concentration (Cmax) of CD.
Time Frame
Up to 8 Days
Title
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD
Description
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.
Time Frame
Up to 8 Days
Title
Minimum Observed Plasma Concentration (Cmin) of CD
Description
Minimum observed plasma concentration (Cmin) of CD.
Time Frame
Up to 8 Days
Title
Degree of Fluctuation (DFL) of CD
Description
DFL = (Cmax-Cmin)/(average plasma concentration).
Time Frame
Up to 8 Days
Title
Swing of CD
Description
Swing = (Cmax-Cmin)/Cmin.
Time Frame
Up to 8 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Hospital /ID# 229974
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Hospital /ID# 230224
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Rush University Medical Center /ID# 229983
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carolina Phase 1, LLC /ID# 239836
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612-8106
Country
United States
Facility Name
The Movement Disorder Clinic of Oklahoma /ID# 238610
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-6378
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 230255
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Parkinson Disease Movement Disorders Clinic /ID# 245791
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Texas Movement Disorder Specialists /ID# 238607
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628-4126
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 239631
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
University of Utah Health Care /ID# 241219
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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