NCT01519284

Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

Detailed description

Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067 5 mg	BIA 9-1067 OPC, Opicapone 5 mg
DRUG	Entacapone	Entacapone 200 mg
DRUG	Placebo	placebo (four times a day)
DRUG	levodopa/carbidopa	standard release levodopa/carbidopa 100/25 mg (single-dose)
DRUG	BIA 9-1067 15 mg	BIA 9-1067 OPC, Opicapone 15 mg
DRUG	BIA 9-1067 30 mg	BIA 9-1067 OPC, Opicapone 30 mg

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-02-01
• Completion: 2011-06-01
• First posted: 2012-01-26
• Last updated: 2015-08-20
• Results posted: 2015-08-20

Locations

1 site across 1 country: Portugal