NCT02609945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

November 16, 2015

Last Update Submit

June 3, 2016

Conditions

Migraine

Keywords

Migraine attacks

Outcome Measures

Primary Outcomes (6)

  • Number of patients with adverse events (AEs) including serious AEs

    up to 23 days

  • Pulmonary function

    Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)

    within 90 min prior to dosing and at specified time points up to 24 hours post-dose

  • Maximum observed plasma drug concentration (Cmax)

    within 15 minutes pre-dose and at specified time points up to 24 hours post-dose

  • Time to maximum observed plasma drug concentration (Tmax)

    within 15 minutes pre-dose and at specified time points up to 24 hours post-dose

  • Area under the concentration time curve (AUC)

    within 15 minutes pre-dose and at specified time points up to 24 hours post-dose

  • Terminal elimination half-life (t½)

    within 15 minutes pre-dose and at specified time points up to 24 hours post-dose

Study Arms (1)

CVT-427 (zolmitriptan inhalation powder)

EXPERIMENTAL

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: zolmitriptanDrug: CVT-427 (zolmitriptan inhalation powder),

Interventions

zolmitriptanDRUG

Oral Tablet and Nasal Spray

Also known as: Zomig®
CVT-427 (zolmitriptan inhalation powder)
CVT-427 (zolmitriptan inhalation powder),DRUG

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

CVT-427 (zolmitriptan inhalation powder)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 001

Daytona Beach, Florida, 32117, United States

Location

Site 002

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

zolmitriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Andrew Eisen, MD

    Acorda Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

US(2)