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

NCT02905227 | Completed Phase 1

• 1 other identifier: TRIP-PK-1041
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Migraine

Keywords

Adult smokers; Asthma; Healthy volunteers

Outcome Measures

Primary Outcomes (4)

• Change in measure of pulmonary function via Spirometry

  within 1 hour prior to dose and up to 24 hours post-dose.

• Maximum observed plasma drug concentration (Cmax)

  up to 24 hours post-dose.

• Maximum observed plasma drug concentration (tmax)

  up to 24 hours post-dose.

• Area under the concentration time curve over the dosing interval (AUC0-last)

  up to 24 hours post-dose.

Secondary Outcomes (1)

• Number of subjects with Adverse Events (AEs) including Serious AEs

  up to 5 days

Study Arms (3)

Adult Asthmatics

EXPERIMENTAL

Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult asthmatics

Drug: CVT-427 (zolmitriptan inhalation powder)

Adult Smokers

EXPERIMENTAL

Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult smokers.

Drug: CVT-427 (zolmitriptan inhalation powder)

Adult Healthy Volunteers

EXPERIMENTAL

Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers.

Drug: CVT-427 (zolmitriptan inhalation powder)

Interventions

CVT-427 (zolmitriptan inhalation powder) DRUG

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

Adult Asthmatics; Adult Healthy Volunteers; Adult Smokers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (3)

Site #103

North Dartmouth, Massachusetts, 02747, United States

Location

Site #102

Lincoln, Nebraska, 68502, United States

Location

Site #101

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Asthma

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Charles Oh, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 14, 2018

Record last verified: 2017-01

Locations

US (3)