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

Parkinson Disease Clinical Trial

Official title:

A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812394
• Other study ID #: CVT-301-010
• Status: Completed
• Phase: Phase 1
• First received: June 22, 2016
• Last updated: October 24, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• CVT-301 (Dose Level 1)
All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.
• CVT-301 (Dose Level 2)
All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.
• Sinemet®
All subjects will receive carbidopa/levodopa tablets administered every 8 hours.

Locations

Country	Name	City	State
United States	Site #001	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma drug concentration (Cmax)		within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.	No
Primary	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.	No
Secondary	Number of subjects with Adverse Events (AEs) including Serious AEs		up to 9 days	Yes