A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

Asthma Clinical Trial

Official title:

A Phase 1 Study of the Safety and Pharmacokinetics (PK) of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633007
• Other study ID #: CVT-301-008
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2015
• Last updated: June 10, 2016
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Eligible subjects will be men or women in good general health with a diagnosis of mild or moderate asthma;

• On a stable regimen of asthma medications for at least 30 days prior to screening;

• Body mass index (BMI) 18 to 32 kg/m2;

• Forced expiratory volume in one second (FEV1) =60% of predicted for race, age, sex, and height;

• FEV1/FVC (forced vital capacity) ratio =70%.

Exclusion Criteria:

• More than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;

• Asthma exacerbation within 8 weeks before screening;

• Unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;

• History of intubation or intensive care unit admission for asthma in the past 5 years;

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CVT-301 (levodopa inhalation powder)
Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa.
• Carbidopa
Administered orally according to the carbidopa dosing schedule.

Other:
• Placebo
Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.

Locations

Country	Name	City	State
United States	Site 003	Dallas	Texas
United States	Site 002	Daytona Beach	Florida
United States	Site 001	North Dartmouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 dose administration and specified time points up to 24 hours after first inhalation	Yes
Secondary	Number of subjects with Adverse Events (AEs) including Serious AEs		up to 12 days	Yes
Secondary	Maximum observed plasma drug concentration (Cmax)		within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose	No
Secondary	Time to maximum observed plasma drug concentration (Tmax)		within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose	No
Secondary	Area under the concentration time curve over the dosing interval (AUC0-last)		within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose	No