Trial record 13 of 43 for:    acorda

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Acorda Therapeutics
Information provided by (Responsible Party):
Acorda Therapeutics Identifier:
First received: November 16, 2015
Last updated: November 18, 2015
Last verified: November 2015
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 Intervention Phase
Drug: zolmitriptan
Drug: CVT-427 (zolmitriptan inhalation powder),
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Number of patients with adverse events (AEs) including serious AEs [ Time Frame: up to 23 days ] [ Designated as safety issue: Yes ]
  • Pulmonary function [ Time Frame: within 90 min prior to dosing and at specified time points up to 24 hours post-dose ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t½) [ Time Frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: November 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:


  • 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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02609945

United States, Florida
Site 001 Recruiting
Daytona Beach, Florida, United States, 32117
Contact: Stephanie Pace    386-366-6425      
United States, Texas
Site 002 Recruiting
Dallas, Texas, United States, 75247
Contact: Erin Chase    214-647-9371      
Sponsors and Collaborators
Acorda Therapeutics
Study Director: Andrew Eisen, MD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics Identifier: NCT02609945     History of Changes
Other Study ID Numbers: TRIP-AM-1035
Study First Received: November 16, 2015
Last Updated: November 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
Migraine attacks

Additional relevant MeSH terms:
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Serotonin 5-HT1 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses processed this record on November 25, 2015