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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02609945
Other study ID # TRIP-AM-1035
Secondary ID
Status Completed
Phase Phase 1
First received November 16, 2015
Last updated June 3, 2016
Start date November 2015
Est. completion date April 2016

Study information

Verified date June 2016
Source Acorda Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Site 002 Dallas Texas
United States Site 001 Daytona Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events (AEs) including serious AEs up to 23 days Yes
Primary 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 Yes
Primary Maximum observed plasma drug concentration (Cmax) within 15 minutes pre-dose and at specified time points up to 24 hours post-dose No
Primary Time to maximum observed plasma drug concentration (Tmax) within 15 minutes pre-dose and at specified time points up to 24 hours post-dose No
Primary Area under the concentration time curve (AUC) within 15 minutes pre-dose and at specified time points up to 24 hours post-dose No
Primary Terminal elimination half-life (t½) within 15 minutes pre-dose and at specified time points up to 24 hours post-dose No
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