Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

NCT03887884 | Completed Phase 1 FDA Drug

• 1 other identifier: CVT-301-012
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  4 days, 3 nights

• 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.

  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.

  4 days, 3 nights

• 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.

  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.

  4 days, 3 nights

• 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 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.

  4 days, 3 nights

Secondary Outcomes (2)

• Columbia-Suicide Severity Rating Scale (C-SSRS).

  4 days, 3 nights

• Incidence of adverse events.

  4 days, 3 nights

Study Arms (2)

CVT-301

EXPERIMENTAL

Single inhaled dose of CVT-301 84 mg

Drug: CVT-301

Sinemet

ACTIVE COMPARATOR

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Drug: Sinemet

Interventions

CVT-301 DRUG

Levodopa Inhalation Powder

CVT-301

Sinemet DRUG

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Sinemet

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (5)

Acorda Site #1003

Long Beach, California, 90806, United States

Location

Acorda Site #1005

Hallandale, Florida, 33009, United States

Location

Acorda Site #1002

Orlando, Florida, 32806, United States

Location

Acorda Site #1004

Atlanta, Georgia, 30331, United States

Location

Acorda Site #1001

Farmington Hills, Michigan, 48334, United States

Location

Related Publications (1)

• Safirstein BE, Ellenbogen A, Zhao P, Henney HR 3rd, Kegler-Ebo DM, Oh C. Pharmacokinetics of Inhaled Levodopa Administered With Oral Carbidopa in the Fed State in Patients With Parkinson's Disease. Clin Ther. 2020 Jun;42(6):1034-1046. doi: 10.1016/j.clinthera.2020.04.004. Epub 2020 May 29.

  PMID: 32482490 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Charles Oh, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: It is a 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 patients who regularly take CD/LD.

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 25, 2019
• Study Start: March 5, 2019
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)