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Clinical Trial
. 2022 Apr:97:68-72.
doi: 10.1016/j.parkreldis.2022.03.012. Epub 2022 Mar 22.

Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum

Matthew Rosebraugh  1 , Sven Stodtmann  2 , Wei Liu  3 , Maurizio F Facheris  4
Affiliations
Clinical Trial

Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum

Matthew Rosebraugh et al. Parkinsonism Relat Disord. 2022 Apr.

Abstract

Introduction: The objective of this study was to compare the pharmacokinetics (PK) of levodopa (LD) from 24-h continuous subcutaneous infusion of foslevodopa/foscarbidopa to the LD pharmacokinetics from 16-h levodopa-carbidopa intestinal gel (LCIG) followed by night-time oral LD/carbidopa (CD) doses.

Methods: This was a Phase 1, open-label, randomized, 2-period crossover study conducted in 25 male and female healthy volunteers.

Results: The LD exposures (Cmax0-16, AUC0-16 and AUC∞) following subcutaneous infusion of 700/35 mg foslevodopa/foscarbidopa over 24 h were similar (<8% difference) to those of LCIG 350/87.5 mg LD/CD administered over 16 h followed by two 100/25 mg LD/CD oral doses at 18 and 21 h after the start of LCIG delivery.

Conclusion: Foslevodopa/foscarbidopa subcutaneous infusion provides levodopa exposures comparable to LCIG throughout the day.

Gov identifier: Not Applicable.

Keywords: Carbidopa; Levodopa; Parkinson's disease; Pharmacokinetics.

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