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

NCT ID: NCT02633839

Last Updated: 2016-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Smoking

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CVT-301

Intervention Type: DRUG

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

Carbidopa

Intervention Type: DRUG

Administered orally according to the carbidopa dosing schedule.

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.

Group Type: EXPERIMENTAL

CVT-301

Intervention Type: DRUG

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

Carbidopa

Intervention Type: DRUG

Administered orally according to the carbidopa dosing schedule.

Interventions

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.

Intervention Type: DRUG

Carbidopa

Administered orally according to the carbidopa dosing schedule.

Intervention Type: DRUG

Other Intervention Names

Lodosyn ®

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harald Murck, MD, PhD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

Site 001

Daytona Beach, Florida, United States

Site 002

Dallas, Texas, United States

Countries

United States

Other Identifiers

CVT-301-007

Identifier Type: -

Identifier Source: org_study_id