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NCT Number: NCT02609945

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 001, Daytona Beach, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zolmitriptan

Drug

Oral Tablet and Nasal Spray

Other names: Zomig®

CVT-427 (zolmitriptan inhalation powder),

Drug

Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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