A Phase 1 interventional study of M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) and M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) 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 2021-11-18.
Sponsored by Zosano Pharma Corporation · Phase 1, Interventional, and Treatment
This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs \~48 hours apart from patch application, in randomized order. Subjects will have final assessment and be dismissed from the study.
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 from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. 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.
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 →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.
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.
Exclusion Criteria:
Presence of three or more of the following CAD risk factors for cardiovascular disease:
A. Current tobacco use (subjects who have smoked within 30 days of screening)
B. Hypertension (systolic BP > 140 or diastolic BP > 90) or receiving anti-hypertensive medication for treatment of hypertension
C. Hyperlipidemia - LDL > 159 mg/dL and/or HDL \< 40 mg/dL (or on prescribed anti-cholesterol treatment)
D. Family history of premature coronary artery disease (CAD) (\< 55 years of age in male first-degree relatives or \< 65 years of age in female first degree relatives)
E. Diabetes mellitus
Any to zolmitriptan administration including:
Use of prescription and over the counter medications within one week of dosing other than the following:
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.
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.
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.
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.
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).
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.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) · Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) · Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups · Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) · Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) · Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups · Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) · Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) · Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups · Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) · Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) · Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups · Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches
Also known as: Treatment A
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups
Also known as: Treatment B
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches
Also known as: Treatment C
Drug page: Zolmitriptan
Zolmitriptan 2.5 mg/0.1 mL nasal spray \[ZOMIG\] single dose
Also known as: Treatment D, Zomig Nasal Spray
Cmax
maximum observed plasma concentration
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose
Adverse Events
Subjects with treatment emergent adverse events
Time frame: 48 hours
Tmax
Time to maximum concentration
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose
| Milestone | ABDC | BCAD | CDBA | DACB |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 |
| Completed | 6 | 6 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
maximum observed plasma concentration
| pg/mL | M207 3.8 mg (Sled) | M207 3.8 mg (MACAP) | M207 3.8 mg (MiniMac) | Zolmitriptan 2.5 mg (Intranasal) |
|---|---|---|---|---|
| Cmax | 11670 ± 30.7 | 9861 ± 93.6 | 11680 ± 66.3 | 3705 ± 43.0 |
Subjects with treatment emergent adverse events
| Participants | M207 3.8 mg (Sled) | M207 3.8 mg (MACAP) | M207 e.8 mg (MiniMac) | Zolmitriptan 2.5 mg (Intranasal) |
|---|---|---|---|---|
| Adverse Events | 18 | 15 | 13 | 4 |
Time to maximum concentration
| hour | M207 3.8 mg (Sled) | M207 3.8 mg (MACAP) | M207 3.8 mg (MiniMac) | Zolmitriptan 2.5 mg (Intranasal) |
|---|---|---|---|---|
| Tmax | 0.529 (0.34 to 0.76) | 0.577 (0.04 to 0.79) | 0.575 (0.33 to 0.77) | 2.000 (0.56 to 4.00) |
Collected over 8 days total, 48 hours per intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| M207 3.8 mg (Sled) | 0/24 (0%) | 0/24 (0%) | 18/24 (75%) |
| M207 3.8 mg (MACAP) | 0/24 (0%) | 0/24 (0%) | 15/24 (62.5%) |
| M207 3.8 mg (MiniMac) | 0/24 (0%) | 0/24 (0%) | 13/24 (54.2%) |
| Zolmitriptan 2.5 mg (Intranasal) | 0/24 (0%) | 0/24 (0%) | 4/24 (16.7%) |
| Event | M207 3.8 mg (Sled) | M207 3.8 mg (MACAP) | M207 3.8 mg (MiniMac) | Zolmitriptan 2.5 mg (Intranasal) |
|---|---|---|---|---|
| Application site discolourationGeneral disorders | 12/24 | 12/24 | 9/24 | 0/24 |
| Abdominal ditensionGastrointestinal disorders | 0/24 | 2/24 | 1/24 | 0/24 |
| ConstipationGastrointestinal disorders | 0/24 | 2/24 | 0/24 | 0/24 |
| NauseaGastrointestinal disorders | 2/24 | 1/24 | 1/24 | 0/24 |
| Application site painGeneral disorders | 1/24 | 1/24 | 2/24 | 0/24 |
| DizzinessNervous system disorders | 2/24 | 1/24 | 0/24 | 0/24 |
| HeadacheNervous system disorders | 1/24 | 2/24 | 1/24 | 1/24 |
| LymphadenopathyBlood and lymphatic system disorders | 0/24 | 1/24 | 1/24 | 0/24 |
| Ear painEar and labyrinth disorders | 0/24 | 0/24 | 1/24 | 0/24 |
| PhotophobiaEye disorders | 0/24 | 0/24 | 1/24 | 0/24 |
| Age, Continuous(years) | ABDC | BCAD | CDBA | DACB | Total |
|---|---|---|---|---|---|
| Mean | 37.7 ± 9.69 | 42.2 ± 4.36 | 35.3 ± 10.09 | 39.5 ± 9.87 | 38.7 ± 8.63 |
| Sex: Female, Male(Participants) | ABDC | BCAD | CDBA | DACB | Total |
|---|---|---|---|---|---|
| Female | 3 | 3 | 3 | 3 | 12 |
| Male | 3 | 3 | 3 | 3 | 12 |
| Ethnicity (NIH/OMB)(Participants) | ABDC | BCAD | CDBA | DACB | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 4 | 4 | 19 |
| Not Hispanic or Latino | 1 | 0 | 2 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ABDC | BCAD | CDBA | DACB | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 | 2 |
| White | 5 | 6 | 6 | 5 | 22 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | ABDC | BCAD | CDBA | DACB | Total |
|---|---|---|---|---|---|
| United States | 6 | 6 | 6 | 6 | 24 |
| Body Mass Index(kg/m2) | ABDC | BCAD | CDBA | DACB | Total |
|---|---|---|---|---|---|
| Mean | 27.153 ± 3.9165 | 27.118 ± 3.1446 | 26.523 ± 4.8929 | 27.242 ± 2.6340 | 27.009 ± 3.5044 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Jun 2019, 0 months.
Results were first posted in Nov 2021, 2 years 4 months after primary completion.
Of 39 industry-sponsored phase 1 interventional studies under Migraine Disorders, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 0 months is below that.
Counting every sponsor, half of 53 studies reached it within 6 months; a quarter within 2 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Zosano Pharma Corporation