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

Patrocinadores

Patrocinador principal: Impax Laboratories, LLC

Fuente Impax Laboratories, LLC
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio November 14, 2016
Fecha de Terminación August 1, 2017
Fecha de finalización primaria August 1, 2017
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Percentage off time during waking hours Last three days collected at the end of each treatment period
Resultado secundario
Medida Periodo de tiempo
Off time and on time hours during in clinic observation Days 1 and 15
MDS-UPDRS Part III Days 1 and 15
Inscripción 28
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: IR CD-LD

Descripción: Immediate Release Tablet containing carbidopa-levodopa flexible dosing

Tipo de intervención: Drug

Nombre de intervención: ER CD-LD

Descripción: Extended Release capsules containing carbidopa-levodopa flexible dosing

Otro nombre: IPX203

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 40 Years

Edad máxima: 100 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Impax Study Director Study Director Impax Laboratories, LLC
Ubicación
Instalaciones:
Investigator 110 | Little Rock, Arkansas, 72205, United States
Site 114 | Little Rock, Arkansas, 72205, United States
Investigator 106 | Boca Raton, Florida, 33486, United States
Investigator 112 | Naples, Florida, 34102, United States
Investigator 113 | Port Charlotte, Florida, 33980, United States
Site 108 | Tampa, Florida, 33613, United States
Investigator 101 | Farmington Hills, Michigan, 48334, United States
Site 103 | Durham, North Carolina, 27705, United States
Investigator 109 | Cleveland, Ohio, 44106, United States
Site 115 | Kirkland, Washington, 98034, United States
Investigator 104 | Spokane, Washington, 99202, United States
Ubicacion Paises

United States

Fecha de verificación

August 2018

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Sequence 1

Tipo: Other

Descripción: Treatment Period 1: ER CD-LD Capsules - 15 days; Washout Period 7-days; Treatment Period 2- IR CD-LD Tablet - 15 days

Etiqueta: Sequence 2

Tipo: Other

Descripción: Treatment Period 1- IR CD-LD Tablet - 15 days; Washout Period 7-days; Treatment Period 2- ER CD-LD Capsules - 15 days

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Treatment

Enmascaramiento: Single (Outcomes Assessor)

Fuente: ClinicalTrials.gov