Overview

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

Status:
Unknown status
Trial end date:
2019-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Intec Pharma Ltd.
Treatments:
Carbidopa
Carbidopa, levodopa drug combination
Levodopa
Criteria
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