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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02633839

Enrollment

Registered

2015-12-17

Start date

2015-12-31

Completion date

2016-06-30

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

Adults

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.

Interventions

DRUGCVT-301

Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.

DRUGCarbidopa

Administered orally according to the carbidopa dosing schedule.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026