Clinical trial NCT02633839: A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Keywords: Adults
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
measure: Time to maximum observed plasma drug concentration (tmax)
timeFrame: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Secondary outcomes:
measure: Change in pulmonary function
timeFrame: within 90 min prior to CVT-301 dose and at specified time points up to 24 hours post-dose
measure: Number of subjects with Adverse Events (AEs) including Serious AEs
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Site 001
state: Florida
city: Dallas
country: United States
facility: Site 002
state: Texas
Study officials:
affiliation: Acorda Therapeutics
name: Harald Murck, MD, PhD
role: STUDY_DIRECTOR
References: