Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Accordion Pill Carbidopa/Levodopa
Sinemet CR 25Mg-100Mg Extended-Release Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- diagnosis of PD consistent with UK Brain Bank Criteria
- 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
- 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:
- Atypical or secondary parkinsonism
- clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator
- severe dyskinesia as assessed by PI
- significant cognitive impairment
- Clinically significant psychiatric illness in opinion of PI
- 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.
- History of GI pathology of clinical significance as determined by PI
- Allergy to study drug or Yellow Dye #5 (tartrazine)
- Unable to swallow large pills
- Active GERD and regular use of PPIs
- Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sinemet
AP CD/LD
Arm Description
Controlled Release 25/100
Outcomes
Primary Outcome Measures
Variability in plasma levodopa concentration
as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD
Secondary Outcome Measures
Variability in plasma levodopa concentration
as assessed by Coefficient of variation (CV) (comparison of AP-CD/LD to IR-CD/LD)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03576638
Brief Title
Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients
Official Title
An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intec Pharma Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sinemet
Arm Type
Active Comparator
Arm Description
Controlled Release 25/100
Arm Title
AP CD/LD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Accordion Pill Carbidopa/Levodopa
Other Intervention Name(s)
AP-CD/LD
Intervention Description
AP 50/500 TID days 2-7
Intervention Type
Drug
Intervention Name(s)
Sinemet CR 25Mg-100Mg Extended-Release Tablet
Other Intervention Name(s)
Sinemet CR
Intervention Description
25/100 1.5 pills five times/day
Primary Outcome Measure Information:
Title
Variability in plasma levodopa concentration
Description
as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD
Time Frame
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.
Secondary Outcome Measure Information:
Title
Variability in plasma levodopa concentration
Description
as assessed by Coefficient of variation (CV) (comparison of AP-CD/LD to IR-CD/LD)
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of PD consistent with UK Brain Bank Criteria
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
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:
Atypical or secondary parkinsonism
clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator
severe dyskinesia as assessed by PI
significant cognitive impairment
Clinically significant psychiatric illness in opinion of PI
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.
History of GI pathology of clinical significance as determined by PI
Allergy to study drug or Yellow Dye #5 (tartrazine)
Unable to swallow large pills
Active GERD and regular use of PPIs
Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrizio Stocchi, MD, PhD
Phone
+39 0652252311
Email
fabrizio.stocchi@sanraffaele.it
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrizio Stocchi, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients
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