MigrainePhase 1NCT04969497
Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers
A Phase 1 study testing Treatment A: M207 3.8 mg "MiniMac", Treatment B: M207 3.8 mg "MACAP" and Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 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, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK 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?
- Treatment A: M207 3.8 mg "MiniMac", Treatment B: M207 3.8 mg "MACAP" and Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 2 Sep 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women or men 18 to 50 years of age (inclusive)
- Good general health with no clinically significant abnormalities as determined by medical history, physical examination, CBC, blood chemistry, urinalysis, and ECG.
- Negative serum pregnancy tests (for female subjects) at the screening and admission visit.
- 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), rings, condom and vaginal spermicide, non-oral hormonal contraceptives (subjects must be stable on non-oral hormonal contraceptives for at least 3 months prior to screening), surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy, hysteroscopic 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 three or more of the following CAD risk factors for cardiovascular disease:
- 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 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
Show all 30Show fewer
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
- History or current Peripheral Vascular Disease
- History or current Ischemic bowel disease
- Hypertension (greater than or equal to 140/90 mmHg at either the screening or admission/baseline visit
- Any history of hepatic impairment defined as ALT > 150 U/L, AST > 130 U/L or bilirubin > 2 times the ULN
- 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 dosing through the duration of the trial
- Use of any prescription anticoagulant within 30 days prior to the first dose through the duration of the trial
- Use of prescription and over the counter medications within one week of dosing other than the following:
- Hormone Replacement Therapy (HRT)
- Non-oral hormonal birth control such as patches, IUD, rings, injections, or implants (all non-oral hormonal contraceptives) are allowed provided the dose has been stable for at least three months prior to screening and may be continued throughout the study
- Antihistamines
- Intermittently used NSAIDS
- Acetaminophen if medically necessary (not more than 1000 mg/day)
- Current known allergy or sensitivity to zolmitriptan or its derivatives or formulations
- Current known allergy or sensitivity to tapes or adhesives
- Use of any other investigational compound within 30 days of planned study drug dosing
- Current use or history of drug and/or alcohol abuse within 6 months of screening and deemed to be clinically significant by the investigator
- History of nasal pathology (e.g., polyps, significant septal deviation or perforation) or abnormal nasal exam (with findings such as nose piercing, gross deformities, and/or severe congestion) deemed to be clinically significant by the investigator
- Body Mass Index (BMI) lower than 18 kg/m2 or greater than 35 kg/m2
- In the opinion of the investigator, the subject is not suitable for the study
- Any positive urine drug result or alcohol test at screening or admission, and/or a positive COVID-19 test performed at admission.
- Any planned COVID-19 vaccination within a week of dosing through the duration of the trial
- Currently a smoker or a nicotine user
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers
This is a single-center, open-label, randomized, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK analysis.
Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. After completion dosing, subjects will be assessed one final time.
Read the detailed description
This is a single-center, open-label, randomized, three-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. Subjects may be dosed in 2 or more separate groups in each period, for example, 24 subjects on one day and 24 subjects on another day.
Plasma samples from the dosing days will be sent to the analytical laboratory for analysis. Tolerability scores for each of the dose levels will be summarized.
After completion of the three dosing days, subjects will be assessed one final time and dismissed from the study.
- Conditions
- Migraine
- Being tested
- Treatment A: M207 3.8 mg "MiniMac", Treatment B: M207 3.8 mg "MACAP", Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
- Keywords
- Pharmacokinetics, Healthy, Volunteer
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: M207 3.8 mg "MiniMac"Drug
Also called MiniMac, M207
Treatment A: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MiniMac" coater and packaged in foil cups
Treatment B: M207 3.8 mg "MACAP"Drug
Also called MACAP, M207
Treatment B: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MACAP" coater and packaged in foil cups
Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Drug
Also called Zomig
Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC | Experimental | Receives interventions in the sequence, A, B, C. Receives: Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 |
| Sequence CAB | Experimental | Receives interventions in the sequence, C, A, B. Receives: Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 |
| Sequence BCA | Experimental | Receives interventions in the sequence, B, C, A. Receives: Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 |
| Sequence CBA | Experimental | Receives interventions in the sequence, C, B, A. Receives: Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 |
| Sequence BAC | Experimental | Receives interventions in the sequence, B, A, C. Receives: Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 |
| Sequence ACB | Experimental | Receives interventions in the sequence, A, C, B. Receives: Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence and type of adverse events reported and observed
Measured: 24 hours
Cmax
Maximum observed plasma concentrations
Measured: 24 hours
Tmax
Time in hours to maximum concentration assessed over 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start24 Jun 2021
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
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
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects are randomized to receive one of six treatment sequences of three open-label treatments 48 hours apart.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zosano Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Kellerman, PharmD, Study director, Zosano Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969497
- Sponsor's protocol ID
- CP-2021-001
- Status last verified
- Sep 2021
- First submitted
- 28 Jun 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- 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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04969497
- Acronym / sponsor ID
- CP-2021-001
- Conditions
- Migraine
- Keywords
- Pharmacokinetics, Healthy, Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zosano Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 20 Jul 2021 (actual)
- 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 is a single-center, open-label, randomized, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK analysis.
Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. After completion dosing, subjects will be assessed one final time.
Detailed description
This is a single-center, open-label, randomized, three-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. Subjects may be dosed in 2 or more separate groups in each period, for example, 24 subjects on one day and 24 subjects on another day.
Plasma samples from the dosing days will be sent to the analytical laboratory for analysis. Tolerability scores for each of the dose levels will be summarized.
After completion of the three 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
- 6
- Model description
- Subjects are randomized to receive one of six treatment sequences of three open-label treatments 48 hours apart.
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Experimental | Drug: Treatment A: M207 3.8 mg "MiniMac", Drug: Treatment B: M207 3.8 mg "MACAP", Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Receives interventions in the sequence, A, B, C. |
| Sequence CAB | Experimental | Drug: Treatment A: M207 3.8 mg "MiniMac", Drug: Treatment B: M207 3.8 mg "MACAP", Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Receives interventions in the sequence, C, A, B. |
| Sequence BCA | Experimental | Drug: Treatment A: M207 3.8 mg "MiniMac", Drug: Treatment B: M207 3.8 mg "MACAP", Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Receives interventions in the sequence, B, C, A. |
| Sequence CBA | Experimental | Drug: Treatment A: M207 3.8 mg "MiniMac", Drug: Treatment B: M207 3.8 mg "MACAP", Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Receives interventions in the sequence, C, B, A. |
| Sequence BAC | Experimental | Drug: Treatment A: M207 3.8 mg "MiniMac", Drug: Treatment B: M207 3.8 mg "MACAP", Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Receives interventions in the sequence, B, A, C. |
| Sequence ACB | Experimental | Drug: Treatment A: M207 3.8 mg "MiniMac", Drug: Treatment B: M207 3.8 mg "MACAP", Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Receives interventions in the sequence, A, C, B. |
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 (inclusive)
- Good general health with no clinically significant abnormalities as determined by medical history, physical examination, CBC, blood chemistry, urinalysis, and ECG.
- Negative serum pregnancy tests (for female subjects) at the screening and admission visit.
- 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), rings, condom and vaginal spermicide, non-oral hormonal contraceptives (subjects must be stable on non-oral hormonal contraceptives for at least 3 months prior to screening), surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy, hysteroscopic 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 three or more of the following CAD risk factors for cardiovascular disease:
- 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 dosing through the duration of the trial
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 |
|---|---|---|
| Treatment A: M207 3.8 mg "MiniMac"Also: MiniMac, M207Treatment A: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MiniMac" coater and packaged in foil cups | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
| Treatment B: M207 3.8 mg "MACAP"Also: MACAP, M207Treatment B: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MACAP" coater and packaged in foil cups | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
| Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0Also: ZomigTreatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 24 hours
Incidence and type of adverse events reported and observed
Cmax
Time frame: 24 hours
Maximum observed plasma concentrations
Tmax
Time frame: 24 hours
Time in hours to maximum concentration assessed over 24 hours
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 17 Sep 2021.
- 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, PharmD 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 Treatment A: M207 3.8 mg "MiniMac", Treatment B: M207 3.8 mg "MACAP" and Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 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 17 Sep 2021. 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?
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 24 hours). The study lists 3 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 17 Sep 2021.