Clinical trial NCT03007888: A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Official title: A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Parkinson's Disease
Keywords: IPX203 (carbidopa-levodopa) Extended-Release capsules
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Levodopa Cmax Following First Dose on Day 1
timeFrame: Day 1
measure: Levodopa Tmax Following First Dose on Day 1
timeFrame: Day 1
measure: Levodopa t1/2 Following First Dose on Day 1
timeFrame: Day 1
measure: Levodopa AUCt Following First Dose on Day 1
timeFrame: Day 1
measure: Levodopa AUCinf Following First Dose on Day 1
timeFrame: Day 1
measure: Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
timeFrame: Day 1
measure: Carbidopa Cmax Following First Dose on Day 1
timeFrame: Day 1
measure: Carbidopa Tmax Following First Dose on Day 1
timeFrame: Day 1
measure: Carbidopa t1/2 Following First Dose on Day 1
timeFrame: Day 1
measure: Carbidopa AUCt Following First Dose on Day 1
timeFrame: Day 1
measure: Carbidopa AUCinf Following First Dose on Day 1
timeFrame: Day 1
measure: Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
timeFrame: Day 1
measure: Levodopa Cmax Following First Dose on Day 15
timeFrame: Day 15
measure: Levodopa Tmax Following First Dose on Day 15
timeFrame: Day 15
measure: Levodopa AUCtau Following First Dose on Day 15
timeFrame: Day 15
measure: Carbidopa Cmax Following First Dose on Day 15
timeFrame: Day 15
measure: Carbidopa Tmax Following First Dose on Day 15
timeFrame: Day 15
measure: Carbidopa AUCtau Following First Dose on Day 15
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Investigator 110
state: Arkansas
city: Little Rock
country: United States
facility: Site 114
state: Arkansas
city: Boca Raton
country: United States
facility: Investigator 106
state: Florida
city: Naples
country: United States
facility: Investigator 112
state: Florida
city: Port Charlotte
country: United States
facility: Investigator 113
state: Florida
city: Tampa
country: United States
facility: Site 108
state: Florida
city: Farmington Hills
country: United States
facility: Investigator 101
state: Michigan
city: Durham
country: United States
facility: Site 103
state: North Carolina
city: Cleveland
country: United States
facility: Investigator 109
state: Ohio
city: Kirkland
country: United States
facility: Site 115
state: Washington
city: Spokane
country: United States
facility: Investigator 104
state: Washington
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References: