NCT02812394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 parkinson-disease

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

June 22, 2016

Last Update Submit

October 24, 2016

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseEpisodic motor fluctuations (OFF periods)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of subjects with Adverse Events (AEs) including Serious AEs

    up to 9 days

Study Arms (1)

CVT-301

EXPERIMENTAL

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)

Drug: CVT-301 (Dose Level 1)Drug: CVT-301 (Dose Level 2)Drug: Sinemet®

Interventions

CVT-301 (Dose Level 1)DRUG

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

CVT-301
CVT-301 (Dose Level 2)DRUG

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

CVT-301
Sinemet®DRUG

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

Also known as: carbidopa/levodopa
CVT-301

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site #001

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Charles Oh, MD

    Acorda Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

US(1)