MigrainePhase 1NCT02609945
Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
A Phase 1 study testing zolmitriptan and CVT-427 (zolmitriptan inhalation powder), in people with Migraine, run by Acorda Therapeutics at 2 sites in United States.
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. 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?
- zolmitriptan and 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
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2015to Apr 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 002
Dallas, Texas, 75247
Site 001
Daytona Beach, Florida, 32117
About this study
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
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.
Read the detailed 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.
- Conditions
- Migraine
- Being tested
- zolmitriptan, CVT-427 (zolmitriptan inhalation powder),
- Keywords
- Migraine attacks
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolmitriptanDrug
Also called Zomig®
Oral Tablet and Nasal Spray
CVT-427 (zolmitriptan inhalation powder),Drug
Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: zolmitriptan; Drug: CVT-427 (zolmitriptan inhalation powder), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events (AEs) including serious AEs
Measured: up to 23 days
Pulmonary function
Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Measured: within 90 min prior to dosing and at specified time points up to 24 hours post-dose
Maximum observed plasma drug concentration (Cmax)
Measured: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Time to maximum observed plasma drug concentration (Tmax)
Measured: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Area under the concentration time curve (AUC)
Measured: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Terminal elimination half-life (t½)
Measured: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionApr 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Eisen, MD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609945
- Sponsor's protocol ID
- TRIP-AM-1035
- Status last verified
- Jun 2016
- First submitted
- 16 Nov 2015
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02609945
- Acronym / sponsor ID
- TRIP-AM-1035
- Conditions
- Migraine
- Keywords
- Migraine attacks
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Nov 2015 (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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVT-427 (zolmitriptan inhalation powder) | Experimental | Drug: zolmitriptan, Drug: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| zolmitriptanAlso: Zomig®Oral Tablet and Nasal Spray | Drug | CVT-427 (zolmitriptan inhalation powder) |
| CVT-427 (zolmitriptan inhalation powder),Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan. | Drug | CVT-427 (zolmitriptan inhalation powder) |
Primary outcome
Number of patients with adverse events (AEs) including serious AEs
Time frame: up to 23 days
Pulmonary function
Time frame: within 90 min prior to dosing and at specified time points up to 24 hours post-dose
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
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
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
Terminal elimination half-life (t½)
Time frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
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 6 Jun 2016.
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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.
Andrew Eisen, MD study director
Acorda Therapeutics
2 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 zolmitriptan and CVT-427 (zolmitriptan inhalation powder), in people with Migraine, run by Acorda Therapeutics at 2 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 7 inclusion and 5 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Number of patients with adverse events (AEs) including serious AEs (time frame: up to 23 days). The study lists 6 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 6 Jun 2016.