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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02812394

Enrollment

Registered

2016-06-24

Start date

2016-06-30

Completion date

2016-09-30

Last updated

2016-10-26

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

Conditions

Parkinson Disease

Keywords

Parkinson's disease, Episodic motor fluctuations (OFF periods)

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.

Interventions

DRUGCVT-301 (Dose Level 1)

All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.

DRUGCVT-301 (Dose Level 2)

All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.

DRUGSinemet®

All subjects will receive carbidopa/levodopa tablets administered every 8 hours.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Maximum observed plasma drug concentration (Cmax)	within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
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.

Secondary

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

Countries

United States

Outcome results

None listed

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