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

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Opicapone; Drug: Carbidopa Levodopa

• Registration Number: NCT03496870
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-08
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Primary Completion: 2018-07-02
• Study Completion: 2018-07-02
• Status Verified: 2018-09
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Opicapone once daily with Carbidopa/Levodopa	Carbidopa Levodopa	Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 \& 15
Opicapone once daily with Carbidopa/Levodopa	Opicapone	Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 \& 15

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24)	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)	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)	up to 19 days	Maximum plasma concentration
Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)	up to 19 days	Time to maximum plasma concentration
Pharmacokinetic evaluation of levodopa following administration of opicapone: area under the curve (AUC 0-tlast)	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)	up to 15 days	Maximum plasma concentration

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)	up to 19 days	Number of participants with reported adverse events after study treatment.
Pharmacodynamic evaluation of opicapone on S-COMT activity	up to 19 days	Maximum inhibition of S-COMT activity.

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇺🇸 Farmington Hills, Michigan, United States