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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905227
• Other study ID #: TRIP-PK-1041
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2016
• Last updated: February 12, 2018
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Migraine

Intervention

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.

Locations

Country	Name	City	State
United States	Site #101	Dallas	Texas
United States	Site #102	Lincoln	Nebraska
United States	Site #103	North Dartmouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measure of pulmonary function via Spirometry		within 1 hour prior to dose and up to 24 hours post-dose.
Primary	Maximum observed plasma drug concentration (Cmax)		up to 24 hours post-dose.
Primary	Maximum observed plasma drug concentration (tmax)		up to 24 hours post-dose.
Primary	Area under the concentration time curve over the dosing interval (AUC0-last)		up to 24 hours post-dose.
Secondary	Number of subjects with Adverse Events (AEs) including Serious AEs		up to 5 days