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Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609945
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: zolmitriptan Drug: CVT-427 (zolmitriptan inhalation powder), Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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.

Drug: zolmitriptan
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.




Primary Outcome Measures :
  1. Number of patients with adverse events (AEs) including serious AEs [ Time Frame: up to 23 days ]
  2. 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)

  3. Maximum observed plasma drug concentration (Cmax) [ Time Frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose ]
  4. 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 ]
  5. 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 ]
  6. Terminal elimination half-life (t½) [ Time Frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, Florida
Site 001
Daytona Beach, Florida, United States, 32117
United States, Texas
Site 002
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Acorda Therapeutics
Investigators
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Study Director: Andrew Eisen, MD Acorda Therapeutics

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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02609945    
Other Study ID Numbers: TRIP-AM-1035
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Keywords provided by Acorda Therapeutics:
Migraine attacks
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxazolidinones
Zolmitriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors