Objective: Characterize levodopa pharmacokinetics (PK) and safety/tolerability of ABBV-951 in healthy volunteers at 3 different subcutaneous (SC) infusion sites: Arm, Abdomen and Thigh

Background: As Parkinson’s disease (PD) progresses, symptoms are no longer well controlled by oral medication due to the narrowing therapeutic window.  ABBV-951 is a new investigational drug being developed for the treatment of PD that provides therapeutic levels of levodopa over a 24-hour period.  Although SC infusions are typically administered to the abdomen, PD patients may prefer alternative infusion sites.  The current work characterizes the relative exposure of levodopa following ABBV-951 infusion to different sites of body.

Method: ABBV-951 was administered SC to the abdomen, arm and thigh to 12 healthy volunteers (45-75 years old) over a 24-hour period in a 3-way randomized crossover design.  Serial plasma PK samples were collected to assay for levodopa concentrations.  Safety and tolerability were assessed throughout the study.

Results: Levodopa exposure was similar and PK profile was overlapping at 3 different SC infusion sites following ABBV-951 infusion.  The ABBV-951 infusion was well tolerated with no notable pattern in adverse event profile across different infusion sites.  All AEs were mild and did not cause discontinuation from the study.

Conclusion: Following ABBV-951 infusion to different SC sites, levodopa exposure, safety and tolerability were similar. Although the abdomen is the most common area for SC infusions, this study suggests that PD patients can choose alternative SC infusion sites, which show interchangeable bioavailability.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/pharmacokinetics-of-abbv-951-following-24-hour-continuous-subcutaneous-infusion-to-arm-abdomen-and-thigh/