A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: CVT-301 (Dose Level 1); Drug: CVT-301 (Dose Level 2); Drug: Sinemet®

• Registration Number: NCT02812394
• Lead Sponsor: Acorda Therapeutics

Brief Summary

This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

Detailed Description

The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
• FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
• Body Mass Index (BMI) between 18 - 30 kg/m2

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Exclusion Criteria

• No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
• Negative drug and alcohol testing;
• Negative pregnancy test for female subjects

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CVT-301	Sinemet®	CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler. CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler. Sinemet® (carbidopa/levodopa)
CVT-301	CVT-301 (Dose Level 1)	CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler. CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler. Sinemet® (carbidopa/levodopa)
CVT-301	CVT-301 (Dose Level 2)	CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler. CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler. Sinemet® (carbidopa/levodopa)

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)	within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Maximum observed plasma drug concentration (Cmax)	within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Events (AEs) including Serious AEs	up to 9 days

Trial Locations

Locations (1)

Site #001; 🇺🇸 Dallas, Texas, United States