Back to resultsA Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Opicapone
Carbidopa Levodopa
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Neurocrine Clinical Site
- Neurocrine Clinical Site
- Neurocrine Clinical Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Opicapone once daily with Carbidopa/Levodopa
Arm Description
Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 & 15
Outcomes
Primary Outcome Measures
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
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
Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax)
Maximum plasma concentration
Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)
Time to maximum plasma concentration
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
Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax)
Maximum plasma concentration
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Number of participants with reported adverse events after study treatment.
Pharmacodynamic evaluation of opicapone on S-COMT activity
Maximum inhibition of S-COMT activity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03496870
Brief Title
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
July 2, 2018 (Actual)
Study Completion Date
July 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opicapone once daily with Carbidopa/Levodopa
Arm Type
Experimental
Arm Description
Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 & 15
Intervention Type
Drug
Intervention Name(s)
Opicapone
Other Intervention Name(s)
BIA 9-1067
Intervention Description
catechol-O-methyltransferase (COMT) inhibitor
Intervention Type
Drug
Intervention Name(s)
Carbidopa Levodopa
Other Intervention Name(s)
Sinemet
Intervention Description
Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor
Primary Outcome Measure Information:
Title
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24)
Description
Area under the plasma concentration versus time curve from 0 to 24 hours for analytes with quantifiable concentrations at 24 hours postdose
Time Frame
up to 19 days
Title
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-tlast)
Description
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
Time Frame
up to 19 days
Title
Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax)
Description
Maximum plasma concentration
Time Frame
up to 19 days
Title
Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)
Description
Time to maximum plasma concentration
Time Frame
up to 19 days
Title
Pharmacokinetic evaluation of levodopa following administration of opicapone: area under the curve (AUC 0-tlast)
Description
Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose
Time Frame
up to 15 days
Title
Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax)
Description
Maximum plasma concentration
Time Frame
up to 15 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Description
Number of participants with reported adverse events after study treatment.
Time Frame
up to 19 days
Title
Pharmacodynamic evaluation of opicapone on S-COMT activity
Description
Maximum inhibition of S-COMT activity.
Time Frame
up to 19 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Neurocrine Clinical Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Neurocrine Clinical Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
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