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

• ClinicalTrials.gov Identifier: NCT03576638
• Recruitment Status: Unknown
• First Posted: July 3, 2018
• Last Update Posted: July 5, 2018
• Sponsor: Intec Pharma Ltd.
• Information provided by (Responsible Party): Intec Pharma Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Drug: Accordion Pill Carbidopa/Levodopa; Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: July 2018
• Estimated Primary Completion Date: January 2019
• Estimated Study Completion Date: January 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sinemet; Controlled Release 25/100	Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet; 25/100 1.5 pills five times/day; Other Name: Sinemet CR
Experimental: AP CD/LD	Drug: Accordion Pill Carbidopa/Levodopa; AP 50/500 TID days 2-7; Other Name: AP-CD/LD

Outcome Measures

Primary Outcome Measures :

1. Variability in plasma levodopa concentration [ 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. ]
   as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD

Secondary Outcome Measures :

1. Variability in plasma levodopa concentration [ 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. ]
   as assessed by Coefficient of variation (CV) (comparison of AP-CD/LD to IR-CD/LD)

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Fabrizio Stocchi, MD, PhD; +39 0652252311; fabrizio.stocchi@sanraffaele.it

Contact: Fabrizio Stocchi, MD, PhD

Sponsors and Collaborators

Intec Pharma Ltd.

More Information

• Responsible Party: Intec Pharma Ltd.
• ClinicalTrials.gov Identifier: NCT03576638
• Other Study ID Numbers: IN 18001; 2018-001209-95 ( EudraCT Number )
• First Posted: July 3, 2018
• Last Update Posted: July 5, 2018
• Last Verified: June 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Aromatic Amino Acid Decarboxylase Inhibitors; Enzyme Inhibitors; Adjuvants, Immunologic; Immunologic Factors; Dopamine Agonists