Migraine
Conditions
Keywords
Migraine attacks
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.
Interventions
DRUGzolmitriptan
Oral Tablet and Nasal Spray
DRUGCVT-427 (zolmitriptan inhalation powder),
Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.
Sponsors
Acorda Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events (AEs) including serious AEs | up to 23 days | — |
| Pulmonary function | within 90 min prior to dosing and at specified time points up to 24 hours post-dose | Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III) |
| Maximum observed plasma drug concentration (Cmax) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | — |
| Time to maximum observed plasma drug concentration (Tmax) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | — |
| Area under the concentration time curve (AUC) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | — |
| Terminal elimination half-life (t½) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | — |
Countries
United States
Outcome results
None listed