Parkinson Disease
Conditions
Brief 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.
Detailed description
An open label, non randomized crossover phase 2 study 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. The study will have a screening period followed by an overnight stay in clinic where Immediate release CD/LD (Sinemet) will be administered five times, approximately every three hours. At specified intervals, blood will be drawn for PK testing. On Days 2-7, subjects will be treated at home with AP CD/LD three times/day, approximately every five hours. Day 8 will be overnight stay in clinic for PK study. AP CD/LD 500mg TID will be dispensed to subjects with specified timelines for PK assessment. Each subject will return to clinic on day 15 for a safety followup visit.
Interventions
DRUGAccordion Pill Carbidopa/Levodopa
AP 50/500 TID days 2-7
DRUGSinemet CR 25Mg-100Mg Extended-Release Tablet
25/100 1.5 pills five times/day
Sponsors
Intec Pharma Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variability in plasma levodopa concentration | Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8. | as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variability in plasma levodopa concentration | Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8. | as assessed by Coefficient of variation (CV) (comparison of AP-CD/LD to IR-CD/LD) |
Contacts
Primary ContactFabrizio Stocchi, MD, PhD
Backup ContactFabrizio Stocchi, MD, PhD
Outcome results
None listed