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A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

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ClinicalTrials.gov Identifier: NCT02812394
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Brief Summary:
This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: CVT-301 (Dose Level 1) Drug: CVT-301 (Dose Level 2) Drug: Sinemet® Phase 1

Detailed Description:
The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
Study Start Date : June 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CVT-301

CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler.

CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler.

Sinemet® (carbidopa/levodopa)

Drug: CVT-301 (Dose Level 1)
All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.

Drug: CVT-301 (Dose Level 2)
All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.

Drug: Sinemet®
All subjects will receive carbidopa/levodopa tablets administered every 8 hours.
Other Name: carbidopa/levodopa




Primary Outcome Measures :
  1. Maximum observed plasma drug concentration (Cmax) [ Time Frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose. ]
  2. Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h) [ Time Frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose. ]

Secondary Outcome Measures :
  1. Number of subjects with Adverse Events (AEs) including Serious AEs [ Time Frame: up to 9 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
  • FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
  • Body Mass Index (BMI) between 18 - 30 kg/m2

Exclusion Criteria:

  • No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
  • Negative drug and alcohol testing;
  • Negative pregnancy test for female subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812394


Locations
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United States, Texas
Site #001
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Acorda Therapeutics
Investigators
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Study Director: Charles Oh, MD Acorda Therapeutics

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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02812394     History of Changes
Other Study ID Numbers: CVT-301-010
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Acorda Therapeutics:
Parkinson's disease
Episodic motor fluctuations (OFF periods)

Additional relevant MeSH terms:
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Carbidopa
Carbidopa, levodopa drug combination
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists