CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
BIA 9-1067 +3 moredrug
Likely dose
BIA 9-1067 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02170376
NCT02170376Phase 1Completed
CompareCT.gov

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

Bial - Portela C S.A.·interventional·Posted Jun 23, 2014·Updated Sep 20, 2016

In Brief

A Phase 1 clinical trial evaluating BIA 9-1067, Entacapone, and 2 other interventions for Parkinson's Disease (PD). Completed, enrolled 80 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease (PD)
CountriesFrance
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2014
Enrollment StartSep 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.0 years ago

Interventions

BIA 9-1067drug

BIA 9-1067 25 mg and 50 mg

Entacaponedrug

Entacapone (ENT), over-encapsulated tablet 200 mg

Placebodrug

PLC, placebo

Levodopa/carbidopadrug

Levodopa/carbidopa, tablet 100/25 mg