NCT02169414

Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics

Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.

Detailed description

A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	BIA 9-1067 5 mg	OPC, Opicapone
DRUG	BIA 9-1067 25 mg	OPC, Opicapone
DRUG	levodopa/carbidopa 100/25	immediate (standard) release levodopa/carbidopa 100/25
DRUG	Placebo	PLC, Placebo
DRUG	levodopa/benserazide 100/25 mg	immediate (standard) release levodopa/benserazide

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2014-06-23
• Last updated: 2015-12-24
• Results posted: 2015-12-24

Locations

1 site across 1 country: France