A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

A Phase 1 Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: CVT-301; Drug: Carbidopa

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Site 001
  • Texas
    • Dallas, Texas, United States, 75247
      • Site 002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index (BMI) 18 to 32 kg/m2;
• Forced expiratory volume in one second (FEV1) ≥80% of predicted for race, age, sex, and height;
• FEV1/FVC (forced vital capacity) ratio ≥70%;
• Smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease [COPD], chronic bronchitis, or other relevant conditions);
• Non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result.

Exclusion Criteria:

• Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
• Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
• History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
• Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute;
• History of syncope within the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults who smoke; Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours. Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.	Drug: CVT-301; Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.; Drug: Carbidopa; Administered orally according to the carbidopa dosing schedule.; Other Names: Lodosyn ®
Experimental: Adults who don't smoke; Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours. Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.	Drug: CVT-301; Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.; Drug: Carbidopa; Administered orally according to the carbidopa dosing schedule.; Other Names: Lodosyn ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma drug concentration (Cmax)	within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Time to maximum observed plasma drug concentration (tmax)	within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Area under the plasma concentration versus time curve (AUC)	within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulmonary function	Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)	within 90 min prior to CVT-301 dose and at specified time points up to 24 hours post-dose
Number of subjects with Adverse Events (AEs) including Serious AEs		up to 3 days

Collaborators and Investigators

• Sponsor: Acorda Therapeutics

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: July 13, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Adults
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Aromatic Amino Acid Decarboxylase Inhibitors; Carbidopa
• Other Study ID Numbers: CVT-301-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No