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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496870
Other study ID # NBI-OPC-1706
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 8, 2018
Est. completion date July 2, 2018

Study information

Verified date September 2018
Source Neurocrine Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date July 2, 2018
Est. primary completion date July 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Neurocrine Clinical Site Farmington Hills Michigan
United States Neurocrine Clinical Site Glendale California
United States Neurocrine Clinical Site Long Beach California

Sponsors (1)

Lead Sponsor Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax) Maximum plasma concentration up to 19 days
Primary Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax) Time to maximum plasma concentration up to 19 days
Primary 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
Primary Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax) Maximum plasma concentration up to 15 days
Secondary Incidence of Treatment-Emergent Adverse Events (safety and tolerability) Number of participants with reported adverse events after study treatment. up to 19 days
Secondary Pharmacodynamic evaluation of opicapone on S-COMT activity Maximum inhibition of S-COMT activity. up to 19 days
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