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Abstract Details

Foslevodopa/foscarbidopa Subcutaneous Infusion Maintains Equivalent Levodopa Exposure to Levodopa-Carbidopa Intestinal Gel Delivered to the Jejunum
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
151
Characterize levodopa pharmacokinetics (PK) following foslevodopa/foscarbidopa subcutaneous (SC) infusion and Levodopa-Carbidopa Intestinal Gel (LCIG) jejunal infusion in healthy volunteers.
LCIG administered over 16 hours offers superior symptomatic control than oral levodopa/carbidopa in patients with advanced Parkinson’s disease (aPD); however, its delivery requires percutaneous endoscopic gastrostomy tube placement.  Foslevodopa/foscarbidopa is a new investigational drug being developed for the treatment of aPD that provides 24-hour therapeutic levels of levodopa following SC delivery.  The current work compares the levodopa PK following foslevodopa/foscarbidopa SC infusion or LCIG infusion.
This study was a randomized, open-label, 2-way crossover study in 20 healthy volunteers.  In each period, subjects received either 24-hour foslevodopa/foscarbidopa SC infusion to the abdomen or a 16-hour LCIG infusion to the jejunum through a nasojejunal tube followed by two separate nighttime oral levodopa/carbidopa (LD/CD) doses.  Serial blood samples were collected to assay for levodopa concentrations.  Equivalent levodopa exposure was predefined as the ratio (ABBV-951/LCIG) and 90% confidence interval of exposure parameters between 0.8 and 1.25.  Safety and tolerability were assessed throughout the study.
Foslevodopa/foscarbidopa SC infusion provided equivalent levodopa levels to LCIG infusion over the 16-hour interval and maintained those levels throughout the nighttime.  The exposure difference between the two regimens was less than 8% and well contained within the defined equivalence range.  Based on PK predictions, the overall levodopa exposures over 24 hours also showed equivalence between foslevodopa/foscarbidopa SC infusion and LCIG.  Both regimens were generally safe and well tolerated in healthy volunteers.  All adverse events considered to be “possibly related” to study drug were mild and did not lead to discontinuation from the study.
Foslevodopa/foscarbidopa SC infusion delivers equivalent levodopa exposure to LCIG infusion with and without nighttime oral LD/CD dosing.
Authors/Disclosures
Matthew Rosebraugh, PhD (AbbVie)
PRESENTER 		Dr. Rosebraugh has received personal compensation for serving as an employee of AbbVie Inc. Dr. Rosebraugh has stock in AbbVie Inc..
Sven Stodtmann (AbbVie) No disclosure on file
Wei Liu Wei Liu has received personal compensation for serving as an employee of AbbVie. Wei Liu has received stock or an ownership interest from AbbVie.
Maurizio Facheris, MD, MSc (Vanqua Bio, Inc) Dr. Facheris has received personal compensation for serving as an employee of Vanqua Bio. Dr. Facheris has or had stock in Vanqua Bio.