A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.

NCT03496870 | Completed Phase 1 FDA Drug

• 1 other identifier: NBI-OPC-1706
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24)

  Area under the plasma concentration versus time curve from 0 to 24 hours for analytes with quantifiable concentrations at 24 hours postdose

  up to 19 days

• Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-tlast)

  Area under the plasma concentration versus time curve from 0 hour to the time of the last measurable concentration for analytes below the limit of quantification at 24 hours postdose

  up to 19 days

• Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax)

  Maximum plasma concentration

  up to 19 days

• Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)

  Time to maximum plasma concentration

  up to 19 days

• Pharmacokinetic evaluation of levodopa following administration of opicapone: area under the curve (AUC 0-tlast)

  Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose

  up to 15 days

• Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax)

  Maximum plasma concentration

  up to 15 days

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (safety and tolerability)

  up to 19 days

• Pharmacodynamic evaluation of opicapone on S-COMT activity

  up to 19 days

Study Arms (1)

Opicapone once daily with Carbidopa/Levodopa

EXPERIMENTAL

Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 \& 15

Drug: Opicapone; Drug: Carbidopa Levodopa

Interventions

Opicapone DRUG

catechol-O-methyltransferase (COMT) inhibitor

Also known as: BIA 9-1067

Opicapone once daily with Carbidopa/Levodopa

Carbidopa Levodopa DRUG

Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor

Also known as: Sinemet

Opicapone once daily with Carbidopa/Levodopa

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment
• Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD
• Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
• Have a body mass index (BMI) of 18 to 40 kg/m2
• Have a modified Hoehn and Yahr stage of ≤4 in the OFF state
• Be able to tolerate an overnight period of 12 hours without CD/LD
• Be in good general health and expected to complete the clinical study as designed

You may not qualify if:

• Are currently pregnant or breastfeeding
• More than 2 alcoholic beverages daily or more than 14 alcoholic beverages weekly within 7 days of Day -1 or consume any alcohol within 48 hours of Day -1.
• Have motor fluctuations during the day (ie, effect of levodopa "wearing off" or having unpredictable "off" periods), or severe or intolerable levodopa-induced dyskinesia
• Have had previous exposure to opicapone, or have an allergy, hypersensitivity, or intolerance to opicapone or other COMT inhibitor.
• Have a history of a medical condition or surgical procedure that might interfere with absorption or metabolism.
• Have a known history of neuroleptic malignant syndrome
• Have an unstable medical condition or chronic disease
• Have taken certain prohibited medications within 28 days of Day -1.
• Have a known or suspected diagnosis of AIDS, or have tested seropositive for HIV
• Have hepatitis A or B
• Have a significant risk of suicidal or violent behavior

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (3)

Neurocrine Clinical Site

Glendale, California, 91206, United States

Location

Neurocrine Clinical Site

Long Beach, California, 90806, United States

Location

Neurocrine Clinical Site

Farmington Hills, Michigan, 48334, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone; carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Chief Medical Officer

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: April 12, 2018
• Study Start: February 8, 2018
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: March 22, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)