Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients

This is an interventional treatment trial for Parkinson Disease Read More

Inclusion Criteria:

1. diagnosis of PD consistent with UK Brain Bank Criteria
2. Stable dose of levodopa/carbidopa IR for at least 4 weeks prior to entry; taking at least 4 doses of IR levodopa during waking hours, and total daily dose of at least 400mg prior to initial screening
3. Stable on all anti-PD medications for 30 days prior to screening. COMT inhibitors are held prior to PK studies on day 1 through day 8

Exclusion Criteria:

1. Atypical or secondary parkinsonism
2. clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator
3. severe dyskinesia as assessed by PI
4. significant cognitive impairment
5. Clinically significant psychiatric illness in opinion of PI
6. history of small bowel or gastric surgery (including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, frequent nausea or emesis regardless of etiology, and symptomatic gastroparesis.
7. History of GI pathology of clinical significance as determined by PI
8. Allergy to study drug or Yellow Dye #5 (tartrazine)
9. Unable to swallow large pills
10. Active GERD and regular use of PPIs
11. Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception