Parkinson Disease Clinical Trial
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
Verified date | September 2018 |
Source | Neurocrine Biosciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Neurocrine Biosciences |
United States,
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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