CompletedNCT03708744Updated Jan 18, 2020Results posted

A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers

A Phase 1 interventional study of A: M207 3.8mg, 30 min, upper arm and B: M207 3.8 mg, 30 min, thigh in Migraine, sponsored by Zosano Pharma Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Zosano Pharma Corporation · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

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.

After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.

Conditions studied

Migraine

Browse trials for

Migraine Disorders 1,657

Keywords

Healthy
Volunteer
Pharmacokinetics

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Zosano Pharma Corporation is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Women or men 18 to 50 years of age.
Good general health with no abnormalities as determined by medical history, physical examination, complete blood count (CBC), blood chemistry, urinalysis, and .
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 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 (≥ 2 years of amenorrhea).
Ability to read, understand, and provide written 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.

Exclusion criteria

Exclusion Criteria:

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, , 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 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
- 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)
- 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 compound within one month of planned study drug dosing
On-going drug or alcohol abuse, or history of either deemed to be 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
(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

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Treatment A
Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
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
Experimental
Treatment B
Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
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
Experimental
Treatment C
Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
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
Active comparator
Treatment D
Treatment D: Intranasal zolmitriptan 2.5 mg
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

Interventions

DrugA: M207 3.8mg, 30 min, upper arm
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
Also known as: A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm
DrugB: M207 3.8 mg, 30 min, thigh
B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
Also known as: B: Zolmitriptan patch 3.8 mg, 30 min, thigh
DrugC: M207 3.8 mg, 1 hr, upper arm
C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
Also known as: C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm
DrugD:zolmitriptan nasal spray
D: 2.5 mg/0.1 mL intranasal zolmitriptan
Also known as: Zomig Nasal Spray

What researchers measure

Primary outcomes

Cmax
maximum observed plasma concentration
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose

Secondary outcomes

Adverse Events
number of subjects that experienced at least one adverse event
Time frame: 24 hours
t(1/2)
apparent half-life
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose

Results

Posted Dec 23, 2019

Participant flow

Participant flow — Overall Study
Milestone	ABCD	BDAC	CADB	DCBA
Started	7	6	5	6
Completed	7	6	4	6
Not completed	0	0	1	0
Withdrew: Withdrawal by subject	0	0	1	0

Outcome measures

PrimaryCmax

maximum observed plasma concentration

Time frame:: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose
Reported as:: Geometric mean · pg/mL

Cmax
pg/mL	Treatment A	Treatment B	Treatment C	Treatment D
Cmax	9180.9 ± 4066.1	5925.9 ± 2353.3	15224.3 ± 12972.9	3758.3 ± 1711.6

SecondaryAdverse Events

number of subjects that experienced at least one adverse event

Time frame:: 24 hours
Reported as:: Number · Participants

Adverse Events
Participants	Treatment A	Treatment B	Treatment C	Treatment D
Adverse Events	4	3	1	1

Secondaryt(1/2)

apparent half-life

Time frame:: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose
Reported as:: Mean · hours

t(1/2)
hours	Treatment A	Treatment B	Treatment C	Treatment D
t(1/2)	2.692 ± 0.486	2.975 ± 1.217	2.959 ± 0.998	4.545 ± 1.535

Adverse events

Collected over 8 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment A	0/23 (0%)	0/23 (0%)	4/23 (17.4%)
Treatment B	0/23 (0%)	0/23 (0%)	3/23 (13%)
Treatment C	0/24 (0%)	0/24 (0%)	1/24 (4.2%)
Treatment D	0/23 (0%)	0/23 (0%)	1/23 (4.3%)

Most frequent other events

Most frequent other events
Event	Treatment A	Treatment B	Treatment C	Treatment D
HeadacheNervous system disorders	2/23	0/23	0/24	0/23
Abdominal discomfortGastrointestinal disorders	0/23	1/23	0/24	0/23
DiarrhoeaGastrointestinal disorders	0/23	1/23	0/24	0/23
DyspepsiaGastrointestinal disorders	1/23	0/23	0/24	0/23
NauseaGastrointestinal disorders	0/23	1/23	1/24	0/23
PresyncopeNervous system disorders	0/23	1/23	0/24	0/23
SomnolenceNervous system disorders	1/23	0/23	0/24	0/23
Intranasal hypoaesthesiaRespiratory, thoracic and mediastinal disorders	0/23	1/23	0/24	0/23
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	0/23	1/23	0/24	1/23

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Entire Study Population
Mean	36.2 ± 9.44

Sex: Female, Male
Sex: Female, Male(Participants)	Entire Study Population
Female	12
Male	12

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Entire Study Population
American Indian or Alaska Native	1
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	15
White	7
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Entire Study Population
United States	24

BMI
BMI(kg/m^2)	Entire Study Population
Mean	26.93 ± 3.264

Study locations

1 site

Hill Top Research, Inc.
Neptune, New Jersey 07753, United States

References and documents

Study documents

Study protocol ↗ · Sep 12, 2018
Statistical analysis plan ↗ · Jan 5, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03708744
Lead sponsor: Zosano Pharma Corporation
Responsible party: Sponsor
First posted: Oct 17, 2018
Start date: Nov 1, 2018
Primary completion: Nov 20, 2018
Completion: Nov 20, 2018
Results posted: Dec 23, 2019
Last update: Jan 18, 2020

Study contacts

Don Kellerman, Pharm.D.

study director · Zosano Pharma Corporation

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Migraine Disorders →

Other studies from this sponsor

Zosano Pharma Corporation

Start the discussion