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Completed

NCT Number: NCT03007888

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

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.

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Key information

Conditions

Advanced Parkinson's Disease

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator 110, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sinemet

Drug

Immediate Release Tablet containing carbidopa-levodopa flexible dosing

Other names: IR CD-LD Tablets

IPX203

Drug

Extended Release capsules containing carbidopa-levodopa flexible dosing

Other names: IPX203 ER CD-LD Capsules

Primary outcomes

  1. Levodopa Cmax Following First Dose on Day 1

    Time frame: 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

  2. Levodopa Tmax Following First Dose on Day 1

    Time frame: 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

  3. Levodopa t1/2 Following First Dose on Day 1

    Time frame: 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

  4. Levodopa AUCt Following First Dose on Day 1

    Time frame: 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

  5. Levodopa AUCinf Following First Dose on Day 1

    Time frame: 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

  6. Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1

    Time frame: 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

  7. Carbidopa Cmax Following First Dose on Day 1

    Time frame: 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

  8. Carbidopa Tmax Following First Dose on Day 1

    Time frame: 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

  9. Carbidopa t1/2 Following First Dose on Day 1

    Time frame: 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

  10. Carbidopa AUCt Following First Dose on Day 1

    Time frame: 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

  11. Carbidopa AUCinf Following First Dose on Day 1

    Time frame: 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

  12. Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1

    Time frame: 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

  13. Levodopa Cmax Following First Dose on Day 15

    Time frame: 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.

  14. Levodopa Tmax Following First Dose on Day 15

    Time frame: 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.

  15. Levodopa AUCtau Following First Dose on Day 15

    Time frame: 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.

  16. Carbidopa Cmax Following First Dose on Day 15

    Time frame: 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.

  17. Carbidopa Tmax Following First Dose on Day 15

    Time frame: 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.

  18. Carbidopa AUCtau Following First Dose on Day 15

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Impax Laboratories, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 2, 2017
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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