A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

Advanced Parkinson's Disease Clinical Trial

Official title:

A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007888
• Other study ID #: IPX203-B16-01
• Status: Completed
• Phase: Phase 2
• Start date: November 14, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: February 2022
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).

Secondary Objectives:

To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

To evaluate the safety of IPX203.

Description:

IPX203 is an investigational product containing CD-LD.

IPX203-B16-01 Study Design:

A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study.

Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.

The study duration will be approximately 8 weeks, including the screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Eligibility will be determined at screening and Visit 1 of the study.

Inclusion Criteria:

• Diagnosed with idiopathic PD at age = 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.

• Hoehn and Yahr Stages 2, 3, or 4

• Montreal Cognitive Assessment (MoCA) score = 24 at Screening Visit in "on" state.

• For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.

• Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1

• Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history).

• By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours

Exclusion Criteria:

• History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.

• Liver enzyme values = 2.5 x the upper limit of normal; or history of severe hepatic impairment.

• History of drug or alcohol abuse within the 12 months prior to Screening.

• Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.

• History of psychosis within the past 10 years.

• Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years.

• Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD Diary.

Related Conditions & MeSH terms

• Advanced Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Sinemet
Immediate Release Tablet containing carbidopa-levodopa flexible dosing
• IPX203
Extended Release capsules containing carbidopa-levodopa flexible dosing

Locations

Country	Name	City	State
United States	Investigator 106	Boca Raton	Florida
United States	Investigator 109	Cleveland	Ohio
United States	Site 103	Durham	North Carolina
United States	Investigator 101	Farmington Hills	Michigan
United States	Site 115	Kirkland	Washington
United States	Investigator 110	Little Rock	Arkansas
United States	Site 114	Little Rock	Arkansas
United States	Investigator 112	Naples	Florida
United States	Investigator 113	Port Charlotte	Florida
United States	Investigator 104	Spokane	Washington
United States	Site 108	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levodopa Cmax Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Levodopa Tmax Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Levodopa t1/2 Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Levodopa AUCt Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Levodopa AUCinf Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Carbidopa Cmax Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Carbidopa Tmax Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Carbidopa t1/2 Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Carbidopa AUCt Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Carbidopa AUCinf Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1	Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose	Day 1
Primary	Levodopa Cmax Following First Dose on Day 15	Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.	Day 15
Primary	Levodopa Tmax Following First Dose on Day 15	Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.	Day 15
Primary	Levodopa AUCtau Following First Dose on Day 15	Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.	Day 15
Primary	Carbidopa Cmax Following First Dose on Day 15	Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.	Day 15
Primary	Carbidopa Tmax Following First Dose on Day 15	Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.	Day 15
Primary	Carbidopa AUCtau Following First Dose on Day 15	Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.	Day 15