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

Acorda Therapeutics

Status and phase: Completed; Phase 1

Conditions: Smoking

Treatments: Drug: CVT-301; Drug: Carbidopa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633839

CVT-301-007

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Adults who smoke

Experimental group

Description:

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.

Treatment:

Drug: CVT-301

Drug: Carbidopa

Adults who don't smoke

Experimental group

Description:

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.

Treatment:

Drug: CVT-301

Drug: Carbidopa