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

NCT ID: NCT03576638

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-01-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sinemet

Controlled Release 25/100

Group Type: ACTIVE_COMPARATOR

Sinemet CR 25Mg-100Mg Extended-Release Tablet

Intervention Type: DRUG

25/100 1.5 pills five times/day

AP CD/LD

Group Type: EXPERIMENTAL

Accordion Pill Carbidopa/Levodopa

Intervention Type: DRUG

AP 50/500 TID days 2-7

Interventions

Accordion Pill Carbidopa/Levodopa

AP 50/500 TID days 2-7

Intervention Type: DRUG

Sinemet CR 25Mg-100Mg Extended-Release Tablet

25/100 1.5 pills five times/day

Intervention Type: DRUG

Other Intervention Names

AP-CD/LD; Sinemet CR

Eligibility 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intec Pharma Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Fabrizio Stocchi, MD, PhD

Role: CONTACT

fabrizio.stocchi@sanraffaele.it

+39 0652252311

Fabrizio Stocchi, MD, PhD

Role: CONTACT

Other Identifiers

2018-001209-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IN 18001

Identifier Type: -

Identifier Source: org_study_id