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

NCT02170376 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-09-20

Study results available
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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).

Conditions

  • Parkinson's Disease (PD)

Interventions

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

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02170376 on ClinicalTrials.gov