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

• Status: Completed
• Trial end date: 2018-07-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurocrine Biosciences
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa; Opicapone

Criteria

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