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

NCT ID: NCT02905227

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-12-31

Brief 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.

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.

Conditions

Migraine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CVT-427 (zolmitriptan inhalation powder)

Intervention Type: DRUG

Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.

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.

Group Type: EXPERIMENTAL

CVT-427 (zolmitriptan inhalation powder)

Intervention Type: DRUG

Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.

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.

Group Type: EXPERIMENTAL

CVT-427 (zolmitriptan inhalation powder)

Intervention Type: DRUG

Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.

Interventions

CVT-427 (zolmitriptan inhalation powder)

Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Oh, MD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

Site #103

North Dartmouth, Massachusetts, United States

Site #102

Lincoln, Nebraska, United States

Site #101

Dallas, Texas, United States

Countries

United States

Other Identifiers

TRIP-PK-1041

Identifier Type: -

Identifier Source: org_study_id