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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • Drug: zolmitriptan
    • Oral Tablet and Nasal Spray
  • Drug: CVT-427 (zolmitriptan inhalation powder),
    • Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Acorda Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrew Eisen, MD, Study Director, Acorda Therapeutics

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