MigrainePhase 1NCT03708744
A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers
A Phase 1 study testing A: M207 3.8mg, 30 min, upper arm, B: M207 3.8 mg, 30 min, thigh and C: M207 3.8 mg, 1 hr, upper arm in people with Migraine, run by Zosano Pharma Corporation at 1 site in United States.
Trial summary
This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- A: M207 3.8mg, 30 min, upper arm, B: M207 3.8 mg, 30 min, thigh and C: M207 3.8 mg, 1 hr, upper arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 20 Nov 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women or men 18 to 50 years of age.
- Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count (CBC), blood chemistry, urinalysis, and ECG.
- Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening.
- Consent of female subjects to use a medically effective method of contraception throughout the entire study period and for 30 days after the subject completes the study. Medically effective methods of contraception that may be used by the subject include abstinence, use of diaphragm and spermicide, intrauterine device (IUD), condom and vaginal spermicide, hormonal contraceptives (subjects must be stable on hormonal contraceptives for at least the prior 3 months), surgical sterilization, and post-menopausal (≥ 2 years of amenorrhea).
- Ability to read, understand, and provide written informed consent that they understand the purpose of the study and procedures required for the study before enrolling in the study, and willingness to comply with all study procedures and restrictions.
Who cannot join
- Evidence of significant history of hepatic, reproductive, gastrointestinal, renal, bleeding, or hematological disorders including coagulation, pulmonary, neurological, respiratory, endocrine, or cardiovascular system abnormalities (especially hypertension, peripheral vascular disease, coronary artery disease, transient ischemic attacks, or cardiac rhythm abnormalities), psychiatric disorders, acute infection, or other conditions that would interfere with study participation or with the absorption, distribution, metabolism, or excretion of drugs.
- Presence of two or more risk factors for cardiovascular disease (family history of premature heart disease, hyperlipidemia, or hypertension)
- Any contraindication to zolmitriptan administration including:
- History of coronary artery disease or coronary vasospasm
- Symptomatic Wolf-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
Show all 30Show fewer
- Peripheral Vascular Disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Any history of hepatic impairment
- History of contact dermatitis or known dermatological disorders that would interfere with the study procedures or assessments
- Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application sites from 2 weeks prior to screening through their last day of study participation
- Use of warfarin within 1 month prior to the first dose or heparin within 1 week prior to study drug administration
- Use of prescription and over the counter medications other than the following:
- Hormone Replacement Therapy (HRT)
- Birth control pills, patches, injections, or implants (all hormonal contraceptives) are allowed provided the dose has been stable for at least one month prior to screening and may be continued throughout the study
- Antihistamines
- Intermittently used NSAIDS
- Acetaminophen if medically necessary (not more than 2 g/day)
- Exceptions may be allowed on a case by case basis
- Subjects who have a known allergy or sensitivity to zolmitriptan or its derivatives or formulations
- Known allergy or sensitivity to tapes, adhesives, or zolmitriptan
- Regular or recent intake of prescription drugs, particularly drugs with an influence on blood pressure.
- Use of any other investigational compound within one month of planned study drug dosing
- On-going drug or alcohol abuse, or history of either deemed to be clinically significant by the investigator
- Systolic BP (measured after remaining sitting for 5 minutes) greater than 140 mmHg and diastolic BP greater than 90 mmHg at screening
- History of nasal pathology (e.g., polyps) or abnormal nasal exam
- Body Mass Index (BMI) greater than 35 kg/m2
- If, in the opinion of the investigator, the subject is not suitable for the study
- Any positive urine drug screen result or alcohol breath test
Trial locations and contacts
1 site in 1 country.
United States1 site
Hill Top Research, Inc.
Neptune City, New Jersey, 07753
About this study
Official title: A Randomized Open-label 4-way Crossover Study to Compare the PK, Safety, and Tolerability of M207 at Two Different Application Locations for 30 Minutes With Intranasal Zolmitriptan 2.5 mg and 1 Hour Wear Time in Healthy Volunteers
This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
Dosing will occur approximately 48 hours apart, until completion of dosing in randomized order per the treatment sequence tables. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized.
After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
Read the detailed description
This is a single-center, open-label, randomized, four-way crossover study to compare the pharmacokinetics, safety and tolerability of:
M207 3.8 mg administered to the upper arm to M207 3.8 mg administered to the thigh, particularly with respect to skin irritation (erythema, edema, bruising, bleeding):
M207 3.8 mg worn for 30 minutes on the upper arm to M207 3.8 mg worn for 1 hour on the upper arm; and M207 3.8 mg to intranasal zolmitriptan 2.5 mg.
Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
M207 application sites will be observed for erythema, edema, bruising, and bleeding at various timepoints throughout the study.
Dosing will occur approximately 48 hours apart, until completion of dosing in randomized order per the treatment sequence tables. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized.
After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
- Conditions
- Migraine
- Being tested
- A: M207 3.8mg, 30 min, upper arm, B: M207 3.8 mg, 30 min, thigh, C: M207 3.8 mg, 1 hr, upper arm, D:zolmitriptan nasal spray
- Keywords
- Healthy, Volunteer, Pharmacokinetics
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: M207 3.8mg, 30 min, upper armDrug
Also called A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
B: M207 3.8 mg, 30 min, thighDrug
Also called B: Zolmitriptan patch 3.8 mg, 30 min, thigh
B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
C: M207 3.8 mg, 1 hr, upper armDrug
Also called C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm
C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
D:zolmitriptan nasal sprayDrug
Also called Zomig Nasal Spray
D: 2.5 mg/0.1 mL intranasal zolmitriptan
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) Receives: Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray |
| Treatment B | Experimental | Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) Receives: Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray |
| Treatment C | Experimental | Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) Receives: Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray |
| Treatment D | Active comparator | Treatment D: Intranasal zolmitriptan 2.5 mg Receives: Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed plasma concentration
Measured: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose
Secondary outcomes (2)
Adverse Events
number of subjects that experienced at least one adverse event
Measured: 24 hours
t(1/2)
apparent half-life
Measured: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 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 posted17 Oct 2018
- Study start1 Nov 2018
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, open-label four-way crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zosano Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Kellerman, Pharm.D., Study director, Zosano Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708744
- Sponsor's protocol ID
- CP-2018-002
- Status last verified
- Jan 2020
- First submitted
- 9 Oct 2018
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label 4-way Crossover Study to Compare the PK, Safety, and Tolerability of M207 at Two Different Application Locations for 30 Minutes With Intranasal Zolmitriptan 2.5 mg and 1 Hour Wear Time in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03708744
- Acronym / sponsor ID
- CP-2018-002
- Conditions
- Migraine
- Keywords
- Healthy, Volunteer, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zosano Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
Dosing will occur approximately 48 hours apart, until completion of dosing in randomized order per the treatment sequence tables. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized.
After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
Detailed description
This is a single-center, open-label, randomized, four-way crossover study to compare the pharmacokinetics, safety and tolerability of:
M207 3.8 mg administered to the upper arm to M207 3.8 mg administered to the thigh, particularly with respect to skin irritation (erythema, edema, bruising, bleeding):
M207 3.8 mg worn for 30 minutes on the upper arm to M207 3.8 mg worn for 1 hour on the upper arm; and M207 3.8 mg to intranasal zolmitriptan 2.5 mg.
Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
M207 application sites will be observed for erythema, edema, bruising, and bleeding at various timepoints throughout the study.
Dosing will occur approximately 48 hours apart, until completion of dosing in randomized order per the treatment sequence tables. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized.
After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, open-label four-way crossover
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: A: M207 3.8mg, 30 min, upper arm, Drug: B: M207 3.8 mg, 30 min, thigh, Drug: C: M207 3.8 mg, 1 hr, upper arm, Drug: D:zolmitriptan nasal sprayTreatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) |
| Treatment B | Experimental | Drug: A: M207 3.8mg, 30 min, upper arm, Drug: B: M207 3.8 mg, 30 min, thigh, Drug: C: M207 3.8 mg, 1 hr, upper arm, Drug: D:zolmitriptan nasal sprayTreatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) |
| Treatment C | Experimental | Drug: A: M207 3.8mg, 30 min, upper arm, Drug: B: M207 3.8 mg, 30 min, thigh, Drug: C: M207 3.8 mg, 1 hr, upper arm, Drug: D:zolmitriptan nasal sprayTreatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) |
| Treatment D | Active comparator | Drug: A: M207 3.8mg, 30 min, upper arm, Drug: B: M207 3.8 mg, 30 min, thigh, Drug: C: M207 3.8 mg, 1 hr, upper arm, Drug: D:zolmitriptan nasal sprayTreatment D: Intranasal zolmitriptan 2.5 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women or men 18 to 50 years of age.
- Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count (CBC), blood chemistry, urinalysis, and ECG.
- Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening.
- Consent of female subjects to use a medically effective method of contraception throughout the entire study period and for 30 days after the subject completes the study. Medically effective methods of contraception that may be used by the subject include abstinence, use of diaphragm and spermicide, intrauterine device (IUD), condom and vaginal spermicide, hormonal contraceptives (subjects must be stable on hormonal contraceptives for at least the prior 3 months), surgical sterilization, and post-menopausal (≥ 2 years of amenorrhea).
- Ability to read, understand, and provide written informed consent that they understand the purpose of the study and procedures required for the study before enrolling in the study, and willingness to comply with all study procedures and restrictions.
Key exclusion criteria (30 listed)
- Evidence of significant history of hepatic, reproductive, gastrointestinal, renal, bleeding, or hematological disorders including coagulation, pulmonary, neurological, respiratory, endocrine, or cardiovascular system abnormalities (especially hypertension, peripheral vascular disease, coronary artery disease, transient ischemic attacks, or cardiac rhythm abnormalities), psychiatric disorders, acute infection, or other conditions that would interfere with study participation or with the absorption, distribution, metabolism, or excretion of drugs.
- Presence of two or more risk factors for cardiovascular disease (family history of premature heart disease, hyperlipidemia, or hypertension)
- Any contraindication to zolmitriptan administration including:
- History of contact dermatitis or known dermatological disorders that would interfere with the study procedures or assessments
- Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application sites from 2 weeks prior to screening through their last day of study participation
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 |
|---|---|---|
| A: M207 3.8mg, 30 min, upper armAlso: A: Zolmitriptan patch, 3.8 mg, 30 min, upper armA: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| B: M207 3.8 mg, 30 min, thighAlso: B: Zolmitriptan patch 3.8 mg, 30 min, thighB: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| C: M207 3.8 mg, 1 hr, upper armAlso: C: Zolmitriptan patch, 3.8 mg, 1 hour, upper armC: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| D:zolmitriptan nasal sprayAlso: Zomig Nasal SprayD: 2.5 mg/0.1 mL intranasal zolmitriptan | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Cmax
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose
maximum observed plasma concentration
2 secondary outcomes
Adverse Events
Time frame: 24 hours
t(1/2)
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Don Kellerman, Pharm.D. study director
Zosano Pharma Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A: M207 3.8mg, 30 min, upper arm, B: M207 3.8 mg, 30 min, thigh and C: M207 3.8 mg, 1 hr, upper arm in people with Migraine, run by Zosano Pharma Corporation at 1 site 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 30 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose). 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 18 Jan 2020.