Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

Overview

This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.

Full Title of Study: “Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 28, 2019

Detailed Description

The study duration includes a screening period followed by an overnight stay in the center (4 days, 3 nights) to complete 2 treatments, including a 48-hour interval between the treatments, and a follow-up phone call 1-2 days after discharge from the center. On each of two treatment days, subjects will consume a standard high fat meal and then receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such that each subject receives both Treatment A and Treatment B over the 2 treatment days, randomized 1:1 to the treatment sequence AB or BA.

Interventions

  • Drug: CVT-301
    • Levodopa Inhalation Powder
  • Drug: Sinemet
    • Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Arms, Groups and Cohorts

  • Experimental: CVT-301
    • Single inhaled dose of CVT-301 84 mg
  • Active Comparator: Sinemet
    • Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Clinical Trial Outcome Measures

Primary Measures

  • Maximum plasma concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson’s disease.
    • Time Frame: 4 days, 3 nights
    • Maximum observed plasma drug concentration (Cmax) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson’s disease (PD) in a fed state.
  • Total plasma concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson’s disease.
    • Time Frame: 4 days, 3 nights
    • Area under the plasma concentration curve from time 0 to the concentration at 4 hours (AUCo-4h) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson’s disease (PD) in a fed state.
  • Terminal half-life of a single inhaled dose of CVT-30184 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson’s disease.
    • Time Frame: 4 days, 3 nights
    • Terminal half-life (t1/2)of a single inhaled dose of CVT-30184 and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson’s disease (PD) in a fed state.
  • Time to maximum observed plasma drug concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson’s disease.
    • Time Frame: 4 days, 3 nights
    • Time to maximum observed plasma drug concentration (Tmax) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson’s disease (PD) in a fed state.

Secondary Measures

  • Columbia-Suicide Severity Rating Scale (C-SSRS).
    • Time Frame: 4 days, 3 nights
    • To evaluate the safety and tolerability of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25/100 mg) under fed conditions in PD patients using the Columbia-Suicide Severity Rating Scale (C-SSRS). The (C-SSRS) is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes. Subscales not applicable.
  • Incidence of adverse events.
    • Time Frame: 4 days, 3 nights
    • To evaluate the safety and tolerability of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25/100 mg) under fed conditions in PD patients by accessing adverse events.

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women between the ages of 30 and 85 years, inclusive. – Have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years. – Classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity. – Stable on other non levodopa PD medications for at least 4 weeks prior to the Screening Visit. – Subjects must have normal cognition as confirmed by a score of ≥ 25 on the Mini Mental State Examination (MMSE), performed in the ON state. – Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%. – Body Mass Index (BMI) between 18 – 32 kg/m2, inclusive. Exclusion Criteria:

  • Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit. – Chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years. – History of any cancer in the past 5 years with the exception of successfully treated basal cell carcinoma. – Narrow angle glaucoma or a history of peptic ulcer disease less than 1 year prior to screening. – Previous surgery for PD (including but not limited to deep brain stimulation or cell transplantation). – Current use of nicotine patch or tobacco-containing products including cigarettes, electronic cigarettes, cigars, chewing tobacco, pipe tobacco or snuff or use within 4 weeks prior to the Screening Visit, or expected use during the study. – Marijuana smoking within 4 weeks prior to the Screening Visit, or expected smoking/inhalation during the study.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Acorda Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charles Oh, MD, Study Director, Acorda Therapeutics

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