Back to resultsSafety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
Primary Purpose
Migraine
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
zolmitriptan
CVT-427 (zolmitriptan inhalation powder),
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine attacks
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.
Sites / Locations
- Site 001
- Site 002
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CVT-427 (zolmitriptan inhalation powder)
Arm Description
Periods 1-2: Subjects will receive Zomig oral tablet in Period 1 and Zomig nasal spray in Period 2, 1 hour apart. Periods 3-6: Subjects will receive CVT-427 (dose levels (DL) 1, 2, 3 and 4), administered in ascending order provided that safety and tolerability data are observed to be adequate to allow dose escalation, approximately 24 hours after preceding DL.
Outcomes
Primary Outcome Measures
Number of patients with adverse events (AEs) including serious AEs
Pulmonary function
Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Maximum observed plasma drug concentration (Cmax)
Time to maximum observed plasma drug concentration (Tmax)
Area under the concentration time curve (AUC)
Terminal elimination half-life (t½)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02609945
Brief Title
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
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine attacks
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVT-427 (zolmitriptan inhalation powder)
Arm Type
Experimental
Arm Description
Periods 1-2: Subjects will receive Zomig oral tablet in Period 1 and Zomig nasal spray in Period 2, 1 hour apart.
Periods 3-6: Subjects will receive CVT-427 (dose levels (DL) 1, 2, 3 and 4), administered in ascending order provided that safety and tolerability data are observed to be adequate to allow dose escalation, approximately 24 hours after preceding DL.
Intervention Type
Drug
Intervention Name(s)
zolmitriptan
Other Intervention Name(s)
Zomig®
Intervention Description
Oral Tablet and Nasal Spray
Intervention Type
Drug
Intervention Name(s)
CVT-427 (zolmitriptan inhalation powder),
Intervention Description
Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.
Primary Outcome Measure Information:
Title
Number of patients with adverse events (AEs) including serious AEs
Time Frame
up to 23 days
Title
Pulmonary function
Description
Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Time Frame
within 90 min prior to dosing and at specified time points up to 24 hours post-dose
Title
Maximum observed plasma drug concentration (Cmax)
Time Frame
within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Title
Time to maximum observed plasma drug concentration (Tmax)
Time Frame
within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Title
Area under the concentration time curve (AUC)
Time Frame
within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Title
Terminal elimination half-life (t½)
Time Frame
within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Eisen, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 001
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Site 002
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
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