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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in measure of pulmonary function via Spirometry
    • Time Frame: 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.
  • Maximum observed plasma drug concentration (tmax)
    • Time Frame: 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.

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Acorda Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charles Oh, MD, Study Director, Acorda Therapeutics

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