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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: Oxazolidinones; Zolmitriptan

Criteria

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).