A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder

February 12, 2018 updated by: Acorda Therapeutics

A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers

This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Site #103
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Site #102
    • Texas
      • Dallas, Texas, United States, 75247
        • Site #101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • eligible subjects will be men or women aged 18 to 65 years inclusive;
  • body mass index (BMI) 18 to 30 kg/m2;
  • healthy adults must be in general good health with no clinically significant abnormalities that would affect ability to complete study.
  • subjects with asthma must be non-smokers who have a forced expiratory volume in one second (FEV1) ≥ 60% of predicted for race, age, sex, and height;
  • subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day history or the equivalent consumption of cigars and a positive result for plasma cotinine.

Exclusion Criteria:

  • subjects with asthma will be excluded for more than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
  • asthma exacerbation within 8 weeks of before screening;
  • unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
  • history of intubation or intensive care unit admission for asthma in the past 5 years.
  • Subjects who smoke will be excluded if they have intrinsic lung disease including asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of <60% of predicted and a score of ≥2 on the Medical Research Council Dsypnea Scale (MRC);
  • any cardiovascular risk factor or contraindication for the use of triptans
  • use of nonselective monamine oxidase inhibitors (MAOI), serotonin reuptake inhibitors (SSRIs), propranolol, or cimetidine within 4 weeks prior to the Screening Visit, or planned use during the study;
  • positive serology test (hepatitis B virus surface antigen [HBsAg], hepatitis C virus [HCV] antibody, human immunodeficiency virus [HIV] 1 & 2 antibodies).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult Asthmatics
Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult asthmatics
Drug: CVT-427 (zolmitriptan inhalation powder)
Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.
Experimental: Adult Smokers
Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult smokers.
Drug: CVT-427 (zolmitriptan inhalation powder)
Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.
Experimental: Adult Healthy Volunteers
Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers.
Drug: CVT-427 (zolmitriptan inhalation powder)
Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in measure of pulmonary function via Spirometry
Time Frame: within 1 hour prior to dose and up to 24 hours post-dose.
within 1 hour prior to dose and up to 24 hours post-dose.
Maximum observed plasma drug concentration (Cmax)
Time Frame: up to 24 hours post-dose.
up to 24 hours post-dose.
Maximum observed plasma drug concentration (tmax)
Time Frame: up to 24 hours post-dose.
up to 24 hours post-dose.
Area under the concentration time curve over the dosing interval (AUC0-last)
Time Frame: up to 24 hours post-dose.
up to 24 hours post-dose.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with Adverse Events (AEs) including Serious AEs
Time Frame: up to 5 days
up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Investigators

  • Study Director: Charles Oh, MD, Acorda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIP-PK-1041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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