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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609945
• Other study ID #: TRIP-AM-1035
• 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

• Migraine

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