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NCT Number: NCT03496870

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neurocrine Clinical Site, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Opicapone

Drug

catechol-O-methyltransferase (COMT) inhibitor

Other names: BIA 9-1067

Carbidopa Levodopa

Drug

Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor

Other names: Sinemet

Primary outcomes

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

    Time frame: up to 19 days

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

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

    Time frame: up to 19 days

    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

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

    Time frame: up to 19 days

    Maximum plasma concentration

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

    Time frame: up to 19 days

    Time to maximum plasma concentration

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

    Time frame: up to 15 days

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

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

    Time frame: up to 15 days

    Maximum plasma concentration

Secondary outcomes

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

    Time frame: up to 19 days

    Number of participants with reported adverse events after study treatment.

  2. Pharmacodynamic evaluation of opicapone on S-COMT activity

    Time frame: up to 19 days

    Maximum inhibition of S-COMT activity.

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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