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

Completed · Phase 1

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT02905227

Run by

Acorda Therapeutics

People needed

60

Starts

2016-09-01

Expected to finish

2016-12-01

Last updated by the study team

2018-02-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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