NCT02170376

The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics

The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (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 repeated dosing of once-daily 25, 50 and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK), in comparison to placebo and 200 mg entacapone (ENT).

Detailed description

This study was a single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 20 healthy subjects each (10 male and 10 female). The clinical part included a screening examination within 3 weeks before the first institutionalization, an ambulatory period of 11 days (from Day 1 evening to Day 11 evening), during which the subjects returned to the clinical unit every evening, followed by an institutionalization of 1.5 days (from Day 11 evening to Day 13 morning (i.e. 14 h after the third administration of levodopa/carbidopa). Then, a follow-up visit at 5 to 9 days after collection of the last PK blood sample (i.e. Day 13). The maximum total duration of the clinical study, including the 21-day screening period and the post-study follow-up, was expected to be about 39 to 43 days.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	BIA 9-1067	BIA 9-1067 25 mg and 50 mg
DRUG	Entacapone	Entacapone (ENT), over-encapsulated tablet 200 mg
DRUG	Placebo	PLC, placebo
DRUG	Levodopa/carbidopa	Levodopa/carbidopa, tablet 100/25 mg

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2014-06-23
• Last updated: 2016-09-20
• Results posted: 2016-09-20

Locations

1 site across 1 country: France