Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
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|ClinicalTrials.gov Identifier: NCT02609945|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: zolmitriptan Drug: CVT-427 (zolmitriptan inhalation powder),||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||April 2016|
Experimental: CVT-427 (zolmitriptan inhalation powder)
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.
Oral Tablet and Nasal Spray
Other Name: Zomig®
Drug: CVT-427 (zolmitriptan inhalation powder),
Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.
- Number of patients with adverse events (AEs) including serious AEs [ Time Frame: up to 23 days ]
- Pulmonary function [ Time Frame: 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) [ Time Frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose ]
- 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 ]
- 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 ]
- Terminal elimination half-life (t½) [ Time Frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609945
|United States, Florida|
|Daytona Beach, Florida, United States, 32117|
|United States, Texas|
|Dallas, Texas, United States, 75247|
|Study Director:||Andrew Eisen, MD||Acorda Therapeutics|