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A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03978403
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Zosano Pharma Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: M207 3.8 mg (two 1.9 mg Patches in foil pouches) Drug: M207 3.8 mg (two 1.9 mg Patches in cups) Drug: M207 3.8 mg (two 1.9 mg Patches packaged in cups Drug: Zolmitriptan 2.5 mg Nasal Spray [ZOMIG] Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects are randomized to receive one of four treatment sequences of four open-label treatments 48 hours apart.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Open-label Four-way Crossover Study of Pharmacokinetics, Safety, and Tolerability of 3 Formulations of M207 3.8 mg on the Upper Arm for 30 Minutes With Intranasal Zolmitriptan 2.5 mg in Healthy Volunteers
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: M207 3.8 mg (two 1.9 mg Patches in foil pouches, Treatment A)
M207 3.8 mg (Zolmitriptan Microneedle System) administered as two 1.9 mg disposable titanium microneedle patches packaged in a foil pouch (Treatment A)
Drug: M207 3.8 mg (two 1.9 mg Patches in foil pouches)
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches
Other Name: Treatment A

Drug: M207 3.8 mg (two 1.9 mg Patches in cups)
M207 3.8 mg administered as two 1.9 mg Patches packaged in cups
Other Name: Treatment B

Drug: M207 3.8 mg (two 1.9 mg Patches packaged in cups
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches, Treatment A
Other Name: Treatment C

Drug: Zolmitriptan 2.5 mg Nasal Spray [ZOMIG]
Zolmitriptan 2.5 mg/0.1 mL Nasal Spray [ZOMIG]
Other Names:
  • Treatment D
  • Zomig Nasal Spray

Experimental: M207 3.8 mg (two 1.9 mg Patches in cups, treatment B)
M207 3.8 mg (Zolmitriptan Microneedle System) administered as two 1.9 mg disposable titanium microneedle patches packaged in cups (Treatment B)
Drug: M207 3.8 mg (two 1.9 mg Patches in foil pouches)
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches
Other Name: Treatment A

Drug: M207 3.8 mg (two 1.9 mg Patches in cups)
M207 3.8 mg administered as two 1.9 mg Patches packaged in cups
Other Name: Treatment B

Drug: M207 3.8 mg (two 1.9 mg Patches packaged in cups
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches, Treatment A
Other Name: Treatment C

Drug: Zolmitriptan 2.5 mg Nasal Spray [ZOMIG]
Zolmitriptan 2.5 mg/0.1 mL Nasal Spray [ZOMIG]
Other Names:
  • Treatment D
  • Zomig Nasal Spray

Experimental: M207 3.9 mg (two 1.9 mg Patches in cups (Treatment C)
M207 3.8 mg (Zolmitriptan Microneedle System) administered as two 1.9 mg disposable titanium microneedle patches packaged in cups (Treatment C)
Drug: M207 3.8 mg (two 1.9 mg Patches in foil pouches)
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches
Other Name: Treatment A

Drug: M207 3.8 mg (two 1.9 mg Patches in cups)
M207 3.8 mg administered as two 1.9 mg Patches packaged in cups
Other Name: Treatment B

Drug: M207 3.8 mg (two 1.9 mg Patches packaged in cups
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches, Treatment A
Other Name: Treatment C

Drug: Zolmitriptan 2.5 mg Nasal Spray [ZOMIG]
Zolmitriptan 2.5 mg/0.1 mL Nasal Spray [ZOMIG]
Other Names:
  • Treatment D
  • Zomig Nasal Spray

Active Comparator: Zolmitriptan Nasal Spray (Treatment D)
Zolmitriptan 2.5 mg/0.1 ml nasal spray (Zomig® Nasal Spray)
Drug: M207 3.8 mg (two 1.9 mg Patches in foil pouches)
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches
Other Name: Treatment A

Drug: M207 3.8 mg (two 1.9 mg Patches in cups)
M207 3.8 mg administered as two 1.9 mg Patches packaged in cups
Other Name: Treatment B

Drug: M207 3.8 mg (two 1.9 mg Patches packaged in cups
M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches, Treatment A
Other Name: Treatment C

Drug: Zolmitriptan 2.5 mg Nasal Spray [ZOMIG]
Zolmitriptan 2.5 mg/0.1 mL Nasal Spray [ZOMIG]
Other Names:
  • Treatment D
  • Zomig Nasal Spray




Primary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose ]
    maximum observed plasma concentration

  2. Adverse events [ Time Frame: 30 minutes ]
    incidence of adverse events

  3. Tmax [ Time Frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose ]
    Time to maximum concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women or men 18 to 50 years of age (inclusive)
  2. Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count, blood chemistry, urinalysis, and ECG.
  3. Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening and admission/baseline visit.
  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), rings, condom and vaginal spermicide, hormonal contraceptives (subjects must be stable on hormonal contraceptives for at least 3 months prior to screening), surgical sterilization (hysterectomy, bilateral tubal ligation, hysteroscopic 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 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

  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
    • Hypertension (greater than or equal to 140/90 mmHg at either the screening or admission/baseline visit
    • Any history of hepatic impairment defined as alanine transaminase > 150 U/L, aspartate aminotransferase > 130 U/L or bilirubin > 2 times the upper limit of normal
  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 dosing through their last day of study participation
  6. Use of any prescription anticoagulant within 1 month prior to the first dose
  7. Use of prescription and over the counter medications within one week of dosing other than the following:

    • Hormone Replacement Therapy (HRT)
    • Birth control pills, patches, IUD, rings, injections, or implants (all 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
    • Proton Pump Inhibitors (PPIs)
    • Antihistamines
    • Intermittently used NSAIDS
    • Acetaminophen if medically necessary (not more than 1000 mg/day)
    • Exceptions may be allowed on a case by case basis
  8. Subject has a known allergy or sensitivity to zolmitriptan or its derivatives or formulations
  9. Subject has a known allergy or sensitivity to tapes or adhesives
  10. Use of any other investigational compound within 30 days of planned study drug dosing
  11. Current use or history of drug and/or alcohol abuse within 6 months of screening and deemed to be clinically significant by the investigator
  12. History of nasal pathology (e.g., polyps) or abnormal nasal exam deemed to be clinically significant by the investigator
  13. Body Mass Index (BMI) lower than 18 kg/m2 or greater than 35 kg/m2
  14. If, in the opinion of the investigator, the subject is not suitable for the study
  15. Any positive urine drug screen result or alcohol test
  16. Subject currently smokes or is a nicotine a user

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978403


Locations
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United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Zosano Pharma Corporation
Investigators
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Study Director: Don Kellerman, PharmD Zosano Pharma Corporation

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Responsible Party: Zosano Pharma Corporation
ClinicalTrials.gov Identifier: NCT03978403     History of Changes
Other Study ID Numbers: CP-2019-002
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zosano Pharma Corporation:
Pharmacokinetics
Healthy
Volunteer
Additional relevant MeSH terms:
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Oxazolidinones
Zolmitriptan
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors