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

Parkinsonism Relat Disord. 2022 Apr:97:68-72. doi: 10.1016/j.parkreldis.2022.03.012. Epub 2022 Mar 22.

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.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiparkinson Agents / therapeutic use
  • Carbidopa*
  • Cross-Over Studies
  • Dopamine Agonists / therapeutic use
  • Drug Combinations
  • Female
  • Gels / therapeutic use
  • Humans
  • Infusions, Subcutaneous
  • Jejunum
  • Levodopa
  • Male
  • Parkinson Disease* / drug therapy

Substances

  • Antiparkinson Agents
  • Dopamine Agonists
  • Drug Combinations
  • Gels
  • Levodopa
  • Carbidopa