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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 April 2023
• Main ID: NCT05094050
• Date of registration: 20/10/2021
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease
• Scientific 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
• Date of first enrolment: January 18, 2022
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05094050
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: ABBV-951

Primary Outcome(s)

Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD [Time Frame: Up to 8 Days]

Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD) [Time Frame: Up to 8 Days]

Minimum Observed Plasma Concentration (Cmin) of CD [Time Frame: Up to 8 Days]

Degree of Fluctuation (DFL) of CD [Time Frame: Up to 8 Days]

Degree of Fluctuation (DFL) of LD [Time Frame: Up to 8 Days]

Minimum Observed Plasma Concentration (Cmin) of LD [Time Frame: Up to 8 Days]

Swing of CD [Time Frame: Up to 8 Days]

Swing of LD [Time Frame: Up to 8 Days]

Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD) [Time Frame: Up to 8 Days]

Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD [Time Frame: Up to 8 Days]

Secondary ID(s)

M20-339

Source(s) of Monetary Support

Please refer to primary and secondary sponsors