Clinical trial NCT02609945: Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
Official title: A Phase 1 First in Human Open-Label Study of the Safety and Pharmacokinetics of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Keywords: Migraine attacks
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in adult healthy volunteers.

Detailed description: Objectives:

* To evaluate the overall safety and tolerability of single, inhaled doses of CVT-427 (zolmitriptan inhalation powder) in healthy adults, with special emphasis on cardiopulmonary effects.
* To describe the pharmacokinetics (PK) of single, inhaled doses of CVT-427, Zomig® Tablet, and Zomig® Nasal Spray in healthy adults.

Eligibility criteria: Inclusion Criteria:

* Healthy adult men or women volunteers aged 18 to 65 years, inclusive;
* Triptan-naïve;
* Body mass index (BMI) between 18 to 30 kg/m2;
* Forced expiratory volume in one second (FEV1) greater than 80% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio greater than or equal to 70%;
* No history of asthma;
* Non-smoking for at least 5 years;
* In good general health with no clinically significant abnormalities or recognized cardiovascular risk factors that preclude use of triptans and that would interfere with participation in this study as determined by medical history, physical examination, electrocardiogram, and clinical laboratory test results; and negative tests for drug and alcohol, serology, and for pregnancy for female subjects of childbearing potential.

Exclusion Criteria:

* Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
* Any cardiovascular risk factor including clinically relevant ECG parameter (e.g., PR interval, QRS deviation) or other clinically significant ECG abnormality;
* History of asthma (including exercise-induced asthma and cold-induced asthma) or chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
* Any flu-like syndrome or other respiratory infections within 4 weeks of CVT-427 administration;
* Unable to tolerate blood draws.

Primary outcomes:
measure: Number of patients with adverse events (AEs) including serious AEs
timeFrame: up to 23 days
measure: Pulmonary function
timeFrame: within 90 min prior to dosing and at specified time points up to 24 hours post-dose
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
measure: Time to maximum observed plasma drug concentration (Tmax)
timeFrame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
measure: Area under the concentration time curve (AUC)
timeFrame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
measure: Terminal elimination half-life (t½)
timeFrame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Site 001
state: Florida
city: Dallas
country: United States
facility: Site 002
state: Texas
Study officials:
affiliation: Acorda Therapeutics
name: Andrew Eisen, MD
role: STUDY_DIRECTOR
References: