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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2, 2018

Interventions

  • Drug: Opicapone
    • catechol-O-methyltransferase (COMT) inhibitor
  • Drug: Carbidopa Levodopa
    • Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor

Arms, Groups and Cohorts

  • Experimental: Opicapone once daily with Carbidopa/Levodopa
    • Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 & 15

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax)
    • Time Frame: up to 19 days
    • Maximum plasma concentration
  • Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)
    • Time Frame: up to 19 days
    • Time to maximum plasma concentration
  • 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
  • Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax)
    • Time Frame: up to 15 days
    • Maximum plasma concentration

Secondary Measures

  • 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.
  • Pharmacodynamic evaluation of opicapone on S-COMT activity
    • Time Frame: up to 19 days
    • Maximum inhibition of S-COMT activity.

Participating in This Clinical Trial

Inclusion Criteria

1. Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment

2. Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD

3. 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

4. Have a body mass index (BMI) of 18 to 40 kg/m2

5. Have a modified Hoehn and Yahr stage of ≤4 in the OFF state

6. Be able to tolerate an overnight period of 12 hours without CD/LD

7. Be in good general health and expected to complete the clinical study as designed

Exclusion Criteria

1. Are currently pregnant or breastfeeding

2. 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.

3. Have motor fluctuations during the day (ie, effect of levodopa "wearing off" or having unpredictable "off" periods), or severe or intolerable levodopa-induced dyskinesia

4. Have had previous exposure to opicapone, or have an allergy, hypersensitivity, or intolerance to opicapone or other COMT inhibitor.

5. Have a history of a medical condition or surgical procedure that might interfere with absorption or metabolism.

6. Have a known history of neuroleptic malignant syndrome

7. Have an unstable medical condition or chronic disease

8. Have taken certain prohibited medications within 28 days of Day -1.

9. Have a known or suspected diagnosis of AIDS, or have tested seropositive for HIV

10. Have hepatitis A or B

11. Have a significant risk of suicidal or violent behavior

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neurocrine Biosciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chief Medical Officer, Study Director, Chief Medical Officer

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