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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03007888
Enrollment
28
Registered
2017-01-02
Start date
2016-11-14
Completion date
2017-08-01
Last updated
2022-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Parkinson's Disease

Keywords

IPX203 (carbidopa-levodopa) Extended-Release capsules

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.

Interventions

DRUGSinemet

Immediate Release Tablet containing carbidopa-levodopa flexible dosing

DRUGIPX203

Extended Release capsules containing carbidopa-levodopa flexible dosing

Sponsors

Impax Laboratories, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Levodopa t1/2 Following First Dose on Day 1Day 1Single 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
Levodopa Cmax Following First Dose on Day 1Day 1Single 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
Levodopa Tmax Following First Dose on Day 1Day 1Single 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
Levodopa AUCt Following First Dose on Day 1Day 1Single 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
Levodopa AUCinf Following First Dose on Day 1Day 1Single 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
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1Day 1Single 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
Carbidopa Cmax Following First Dose on Day 1Day 1Single 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
Carbidopa Tmax Following First Dose on Day 1Day 1Single 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
Carbidopa t1/2 Following First Dose on Day 1Day 1Single 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
Carbidopa AUCt Following First Dose on Day 1Day 1Single 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
Carbidopa AUCinf Following First Dose on Day 1Day 1Single 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
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1Day 1Single 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
Levodopa Cmax Following First Dose on Day 15Day 15Multiple 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.
Levodopa Tmax Following First Dose on Day 15Day 15Multiple 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.
Levodopa AUCtau Following First Dose on Day 15Day 15Multiple 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.
Carbidopa Cmax Following First Dose on Day 15Day 15Multiple 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.
Carbidopa Tmax Following First Dose on Day 15Day 15Multiple 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.
Carbidopa AUCtau Following First Dose on Day 15Day 15Multiple 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.

Countries

United States

Participant flow

Recruitment details

A total of 39 subjects were screened at 10 study sites between November 8, 2016 and August 1, 2017

Pre-assignment details

28 of 39 subjects were enrolled and randomized

Participants by arm

ArmCount
All Study Participants
The recommended first morning dose of IPX203 on Day 1 was based on the subject's prestudy IR CD-LD morning dose The initial IR CD-LD dosing regimen was the same as the subject's stable prestudy regimen (unless s/he was taking a single daily bedtime dose of CR CD-LD, either alone or in combination with IR CD-LD, in which case, the CR CD-LD dose was discontinued and substituted with a 1:1 milligram-equivalent IR CD-LD dose).
28
Total28

Withdrawals & dropouts

PeriodReasonFG000FG001
First Intervention (14 Days)Adverse Event10

Baseline characteristics

CharacteristicAll Study Participants
Age at Parkinson's disease onset58.9 years
STANDARD_DEVIATION 11.8
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
15 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
Age, Continuous66.43 Years
STANDARD_DEVIATION 10.057
Duration of Parkinson's disease7.5 years
STANDARD_DEVIATION 4.8
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Hoehn and Yahr Score
I
0 Participants
Hoehn and Yahr Score
II
24 Participants
Hoehn and Yahr Score
III
4 Participants
Hoehn and Yahr Score
IV
0 Participants
Montreal Cognitive Assessment Score (On State)
30
5 Participants
Montreal Cognitive Assessment Score (On State)
MoCA score<24
0 Participants
Montreal Cognitive Assessment Score (On State)
MoCA score 24 to <26
3 Participants
Montreal Cognitive Assessment Score (On State)
MoCA score 26 to <28
13 Participants
Montreal Cognitive Assessment Score (On State)
MoCA score 28 to <30
7 Participants
Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while Off42.5 units on a scale
STANDARD_DEVIATION 10.6
Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while On19.1 units on a scale
STANDARD_DEVIATION 6.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
26 Participants
Region of Enrollment
United States
28 Participants
Sex: Female, Male
Gender
Female
12 Participants
Sex: Female, Male
Gender
Male
16 Participants
Total Good on time from subject diary9.9 hours
STANDARD_DEVIATION 2.3
Total off time from subject diary5.2 hours
STANDARD_DEVIATION 1.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 270 / 28
other
Total, other adverse events
10 / 282 / 270 / 28
serious
Total, serious adverse events
1 / 280 / 271 / 28

Outcome results

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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa AUCinf Following First Dose on Day 12239.61 ng.h/mLStandard Deviation 1232.234
SinemetCarbidopa AUCinf Following First Dose on Day 1610.44 ng.h/mLStandard Deviation 407.305
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.

Time frame: Day 15

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa AUCtau Following First Dose on Day 151892.39 ng.h/mLStandard Deviation 1017.537
SinemetCarbidopa AUCtau Following First Dose on Day 15415.83 ng.h/mLStandard Deviation 279.487
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa AUCt Following First Dose on Day 11940.51 ng.h/mLStandard Deviation 1095.449
SinemetCarbidopa AUCt Following First Dose on Day 1436.63 ng.h/mLStandard Deviation 286.286
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1117.442 PercentageStandard Deviation 43.4176
SinemetCarbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 10 PercentageStandard Deviation 0
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa Cmax Following First Dose on Day 1500.35 ng/mLStandard Deviation 316.299
SinemetCarbidopa Cmax Following First Dose on Day 1151.50 ng/mLStandard Deviation 103.225
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.

Time frame: Day 15

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa Cmax Following First Dose on Day 15478.66 ng/mLStandard Deviation 290.584
SinemetCarbidopa Cmax Following First Dose on Day 15145.67 ng/mLStandard Deviation 82.541
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa t1/2 Following First Dose on Day 12.015 hourStandard Deviation 0.5159
SinemetCarbidopa t1/2 Following First Dose on Day 11.969 hourStandard Deviation 0.7187
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa Tmax Following First Dose on Day 12.61 hourStandard Deviation 0.655
SinemetCarbidopa Tmax Following First Dose on Day 12.07 hourStandard Deviation 0.675
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.

Time frame: Day 15

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Carbidopa Tmax Following First Dose on Day 152.52 hourStandard Deviation 0.74
SinemetCarbidopa Tmax Following First Dose on Day 152.20 hourStandard Deviation 0.639
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa AUCinf Following First Dose on Day 113968.57 ng.h/mLStandard Deviation 7606.901
SinemetLevodopa AUCinf Following First Dose on Day 14308.37 ng.h/mLStandard Deviation 2123.057
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.

Time frame: Day 15

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa AUCtau Following First Dose on Day 1511213.76 ng.h/MLStandard Deviation 4887.246
SinemetLevodopa AUCtau Following First Dose on Day 153879.39 ng.h/MLStandard Deviation 1744.328
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa AUCt Following First Dose on Day 112107.60 ng.h/mLStandard Deviation 5793.881
SinemetLevodopa AUCt Following First Dose on Day 13747.61 ng.h/mLStandard Deviation 1819.141
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 188.965 PercentageStandard Deviation 21.7583
SinemetLevodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 10 PercentageStandard Deviation 0
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa Cmax Following First Dose on Day 12857.56 ng/mLStandard Deviation 1204.506
SinemetLevodopa Cmax Following First Dose on Day 12173.30 ng/mLStandard Deviation 1240.774
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.

Time frame: Day 15

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa Cmax Following First Dose on Day 152767.96 ng/mLStandard Deviation 1258.525
SinemetLevodopa Cmax Following First Dose on Day 152356.85 ng/mLStandard Deviation 1178.628
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa t1/2 Following First Dose on Day 11.658 hourStandard Deviation 0.4838
SinemetLevodopa t1/2 Following First Dose on Day 11.420 hourStandard Deviation 0.3194
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

Time frame: Day 1

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa Tmax Following First Dose on Day 12.07 hourStandard Deviation 0.997
SinemetLevodopa Tmax Following First Dose on Day 10.94 hourStandard Deviation 0.56
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.

Time frame: Day 15

Population: Randomized subjects who completed both periods

ArmMeasureValue (MEAN)Dispersion
IPX203Levodopa Tmax Following First Dose on Day 151.91 hourStandard Deviation 1.241
SinemetLevodopa Tmax Following First Dose on Day 150.83 hourStandard Deviation 0.439

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026