Migraine Clinical Trial
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
Verified date | June 2016 |
Source | Acorda Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | April 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Site 002 | Dallas | Texas |
United States | Site 001 | Daytona Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Acorda Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with adverse events (AEs) including serious AEs | up to 23 days | Yes | |
Primary | Pulmonary function | Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III) | within 90 min prior to dosing and at specified time points up to 24 hours post-dose | Yes |
Primary | Maximum observed plasma drug concentration (Cmax) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | No | |
Primary | Time to maximum observed plasma drug concentration (Tmax) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | No | |
Primary | Area under the concentration time curve (AUC) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | No | |
Primary | Terminal elimination half-life (t½) | within 15 minutes pre-dose and at specified time points up to 24 hours post-dose | No |
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