A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers

January 1, 2020 updated by: Zosano Pharma Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Women or men 18 to 50 years of age.
  2. Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count (CBC), blood chemistry, urinalysis, and ECG.
  3. Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening.
  4. 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).
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Presence of two or more risk factors for cardiovascular disease (family history of premature heart disease, hyperlipidemia, or hypertension)

  3. 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
    • Peripheral Vascular Disease
    • Ischemic bowel disease
    • Uncontrolled hypertension
    • Any history of hepatic impairment
  4. History of contact dermatitis or known dermatological disorders that would interfere with the study procedures or assessments
  5. 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
  6. Use of warfarin within 1 month prior to the first dose or heparin within 1 week prior to study drug administration

  7. 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
  8. Subjects who have a known allergy or sensitivity to zolmitriptan or its derivatives or formulations
  9. Known allergy or sensitivity to tapes, adhesives, or zolmitriptan
  10. Regular or recent intake of prescription drugs, particularly drugs with an influence on blood pressure.
  11. Use of any other investigational compound within one month of planned study drug dosing
  12. On-going drug or alcohol abuse, or history of either deemed to be clinically significant by the investigator
  13. Systolic BP (measured after remaining sitting for 5 minutes) greater than 140 mmHg and diastolic BP greater than 90 mmHg at screening
  14. History of nasal pathology (e.g., polyps) or abnormal nasal exam
  15. Body Mass Index (BMI) greater than 35 kg/m2
  16. If, in the opinion of the investigator, the subject is not suitable for the study
  17. Any positive urine drug screen result or alcohol breath test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
Other Names:
  • A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm
Drug: B: 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)
Other Names:
  • B: Zolmitriptan patch 3.8 mg, 30 min, thigh
Drug: C: 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)
Other Names:
  • C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm
Drug: D:zolmitriptan nasal spray
D: 2.5 mg/0.1 mL intranasal zolmitriptan
Other Names:
  • Zomig 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
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
Other Names:
  • A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm
Drug: B: 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)
Other Names:
  • B: Zolmitriptan patch 3.8 mg, 30 min, thigh
Drug: C: 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)
Other Names:
  • C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm
Drug: D:zolmitriptan nasal spray
D: 2.5 mg/0.1 mL intranasal zolmitriptan
Other Names:
  • Zomig 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
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
Other Names:
  • A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm
Drug: B: 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)
Other Names:
  • B: Zolmitriptan patch 3.8 mg, 30 min, thigh
Drug: C: 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)
Other Names:
  • C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm
Drug: D:zolmitriptan nasal spray
D: 2.5 mg/0.1 mL intranasal zolmitriptan
Other Names:
  • Zomig Nasal Spray
Active Comparator: Treatment D
Treatment D: Intranasal zolmitriptan 2.5 mg
Drug: A: 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)
Other Names:
  • A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm
Drug: B: 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)
Other Names:
  • B: Zolmitriptan patch 3.8 mg, 30 min, thigh
Drug: C: 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)
Other Names:
  • C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm
Drug: D:zolmitriptan nasal spray
D: 2.5 mg/0.1 mL intranasal zolmitriptan
Other Names:
  • Zomig Nasal Spray

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 24 hours
number of subjects that experienced at least one adverse event
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
apparent half-life
pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zosano Pharma Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Don Kellerman, Pharm.D., Zosano Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-2018-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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