NCT02633839

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

December 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

December 15, 2015

Last Update Submit

July 13, 2016

Conditions

Smoking

Keywords

Adults

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma drug concentration (Cmax)

    within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose

  • Time to maximum observed plasma drug concentration (tmax)

    within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose

  • Area under the plasma concentration versus time curve (AUC)

    within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose

Secondary Outcomes (2)

  • Change in pulmonary function

    within 90 min prior to CVT-301 dose and at specified time points up to 24 hours post-dose

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

    up to 3 days

Study Arms (2)

Adults who smoke

EXPERIMENTAL

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.

Drug: CVT-301Drug: Carbidopa

Adults who don't smoke

EXPERIMENTAL

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.

Drug: CVT-301Drug: Carbidopa

Interventions

CVT-301DRUG

Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.

Adults who don't smokeAdults who smoke
CarbidopaDRUG

Administered orally according to the carbidopa dosing schedule.

Also known as: Lodosyn ®
Adults who don't smokeAdults who smoke

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 001

Daytona Beach, Florida, 32117, United States

Location

Site 002

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Carbidopa

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

MethyldopaDihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsHydrazinesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Harald Murck, MD, PhD

    Acorda Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 17, 2015

Study Start

December 1, 2015

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

US(2)