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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633839
• Other study ID #: CVT-301-007
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2015
• Last updated: July 13, 2016
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: July 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

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.
• Carbidopa
Administered orally according to the carbidopa dosing schedule.

Locations

Country	Name	City	State
United States	Site 002	Dallas	Texas
United States	Site 001	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	Number of subjects with Adverse Events (AEs) including Serious AEs		up to 3 days	Yes