NCT03496870

A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.

A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Opicapone	catechol-O-methyltransferase (COMT) inhibitor
DRUG	Carbidopa Levodopa	Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor

Timeline

• Start date: 2018-02-08
• Primary completion: 2018-07-02
• Completion: 2018-07-02
• First posted: 2018-04-12
• Last updated: 2019-03-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study