MigrainePhase 1NCT02905227
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
A Phase 1 study testing CVT-427 (zolmitriptan inhalation powder) in people with Migraine, run by Acorda Therapeutics at 3 sites in United States.
Trial summary
This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- CVT-427 (zolmitriptan inhalation powder)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2016to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- eligible subjects will be men or women aged 18 to 65 years inclusive;
- body mass index (BMI) 18 to 30 kg/m2;
- healthy adults must be in general good health with no clinically significant abnormalities that would affect ability to complete study.
- subjects with asthma must be non-smokers who have a forced expiratory volume in one second (FEV1) ≥ 60% of predicted for race, age, sex, and height;
- subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day history or the equivalent consumption of cigars and a positive result for plasma cotinine.
Who cannot join
- subjects with asthma will be excluded for more than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
- asthma exacerbation within 8 weeks of before screening;
- unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
- history of intubation or intensive care unit admission for asthma in the past 5 years.
- Subjects who smoke will be excluded if they have intrinsic lung disease including asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of <60% of predicted and a score of ≥2 on the Medical Research Council Dsypnea Scale (MRC);
- any cardiovascular risk factor or contraindication for the use of triptans
- use of nonselective monamine oxidase inhibitors (MAOI), serotonin reuptake inhibitors (SSRIs), propranolol, or cimetidine within 4 weeks prior to the Screening Visit, or planned use during the study;
- positive serology test (hepatitis B virus surface antigen [HBsAg], hepatitis C virus [HCV] antibody, human immunodeficiency virus [HIV] 1 \& 2 antibodies).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site #101
Dallas, Texas, 75247
Site #102
Lincoln, Nebraska, 68502
Site #103
North Dartmouth, Massachusetts, 02747
About this study
Official title: A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers
This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.
Read the detailed description
The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.
- Conditions
- Migraine
- Being tested
- CVT-427 (zolmitriptan inhalation powder)
- Keywords
- Adult smokers, Asthma, Healthy volunteers
- Medical subject headings
- Migraine Disorders, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVT-427 (zolmitriptan inhalation powder)Drug
Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.
| Study group | Role | What they receive |
|---|---|---|
| Adult Asthmatics | Experimental | Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult asthmatics Receives: Drug: CVT-427 (zolmitriptan inhalation powder) |
| Adult Smokers | Experimental | Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult smokers. Receives: Drug: CVT-427 (zolmitriptan inhalation powder) |
| Adult Healthy Volunteers | Experimental | Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers. Receives: Drug: CVT-427 (zolmitriptan inhalation powder) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measure of pulmonary function via Spirometry
Measured: within 1 hour prior to dose and up to 24 hours post-dose.
Maximum observed plasma drug concentration (Cmax)
Measured: up to 24 hours post-dose.
Maximum observed plasma drug concentration (tmax)
Measured: up to 24 hours post-dose.
Area under the concentration time curve over the dosing interval (AUC0-last)
Measured: up to 24 hours post-dose.
Secondary outcomes (1)
Number of subjects with Adverse Events (AEs) including Serious AEs
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Oh, MD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905227
- Sponsor's protocol ID
- TRIP-PK-1041
- Status last verified
- Jan 2017
- First submitted
- 2 Sep 2016
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02905227
- Acronym / sponsor ID
- TRIP-PK-1041
- Conditions
- Migraine
- Keywords
- Adult smokers, Asthma, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.
Detailed description
The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult Asthmatics | Experimental | Drug: CVT-427 (zolmitriptan inhalation powder)Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult asthmatics |
| Adult Smokers | Experimental | Drug: CVT-427 (zolmitriptan inhalation powder)Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult smokers. |
| Adult Healthy Volunteers | Experimental | Drug: CVT-427 (zolmitriptan inhalation powder)Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- eligible subjects will be men or women aged 18 to 65 years inclusive;
- body mass index (BMI) 18 to 30 kg/m2;
- healthy adults must be in general good health with no clinically significant abnormalities that would affect ability to complete study.
- subjects with asthma must be non-smokers who have a forced expiratory volume in one second (FEV1) ≥ 60% of predicted for race, age, sex, and height;
- subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day history or the equivalent consumption of cigars and a positive result for plasma cotinine.
Key exclusion criteria (8 listed)
- subjects with asthma will be excluded for more than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
- asthma exacerbation within 8 weeks of before screening;
- unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
- history of intubation or intensive care unit admission for asthma in the past 5 years.
- Subjects who smoke will be excluded if they have intrinsic lung disease including asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of <60% of predicted and a score of ≥2 on the Medical Research Council Dsypnea Scale (MRC);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVT-427 (zolmitriptan inhalation powder)Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart. | Drug | Adult Asthmatics, Adult Healthy Volunteers, Adult Smokers |
Primary outcome
Change in measure of pulmonary function via Spirometry
Time frame: within 1 hour prior to dose and up to 24 hours post-dose.
Maximum observed plasma drug concentration (Cmax)
Time frame: up to 24 hours post-dose.
Maximum observed plasma drug concentration (tmax)
Time frame: up to 24 hours post-dose.
Area under the concentration time curve over the dosing interval (AUC0-last)
Time frame: up to 24 hours post-dose.
1 secondary outcome
Number of subjects with Adverse Events (AEs) including Serious AEs
Time frame: up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Oh, MD study director
Acorda Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVT-427 (zolmitriptan inhalation powder) in people with Migraine, run by Acorda Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measure of pulmonary function via Spirometry (time frame: within 1 hour prior to dose and up to 24 hours post-dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.