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

• Sponsor: Neurocrine Biosciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03496870
• Collaborator: (none)
• Enrollment: 16
• Locations: 3
• Arm: 1
• Actual Duration (Months): 4.7
• Patients Per Site: 5.3
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Opicapone; Drug: Carbidopa Levodopa	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 8, 2018
• Actual Primary Completion Date: Jul 2, 2018
• Actual Study Completion Date: Jul 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Opicapone; catechol-O-methyltransferase (COMT) inhibitor; Other Names: BIA 9-1067 ; Drug: Carbidopa Levodopa; Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor; Other Names: Sinemet

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax) [up to 19 days]

   Maximum plasma concentration

4. Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax) [up to 19 days]

   Time to maximum plasma concentration

5. 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

6. Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax) [up to 15 days]

   Maximum plasma concentration

Secondary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events (safety and tolerability) [up to 19 days]

   Number of participants with reported adverse events after study treatment.

2. Pharmacodynamic evaluation of opicapone on S-COMT activity [up to 19 days]

   Maximum inhibition of S-COMT activity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurocrine Clinical Site	Glendale	California	United States	91206
2	Neurocrine Clinical Site	Long Beach	California	United States	90806
3	Neurocrine Clinical Site	Farmington Hills	Michigan	United States	48334

Sponsors and Collaborators

• Neurocrine Biosciences

Investigators

• Study Director: Chief Medical Officer, Chief Medical Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neurocrine Biosciences
• ClinicalTrials.gov Identifier: NCT03496870
• Other Study ID Numbers: NBI-OPC-1706
• First Posted: Apr 12, 2018
• Last Update Posted: Mar 22, 2019
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Opicapone

Study Results

No Results Posted as of Mar 22, 2019