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A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03708744
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Zosano Pharma Corporation

Brief 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.


Condition or disease Intervention/treatment Phase
Migraine Drug: M207 Drug: Intranasal zolmitriptan Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, open-label four-way crossover
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A: M207 3.8 mg 30 min upper arm
M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
Drug: M207
M207 3.8 mg administered as two 1.9 mg patches applied to thigh or upper arm
Other Name: Zolmitriptan patch

Active Comparator: B: M207 3.8 mg 30 min thigh
M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
Drug: M207
M207 3.8 mg administered as two 1.9 mg patches applied to thigh or upper arm
Other Name: Zolmitriptan patch

Active Comparator: C: M207 3.8 mg 1 hour upper arm
M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
Drug: M207
M207 3.8 mg administered as two 1.9 mg patches applied to thigh or upper arm
Other Name: Zolmitriptan patch

Active Comparator: D: Intranasal zolmitriptan 2.5 mg
Intranasal zolmitriptan 2.5 mg
Drug: Intranasal zolmitriptan
2.5 mg/0.1 mL intranasal zolmitriptan
Other Names:
  • zolmitriptan nasal spray
  • Zomig Nasal Spray




Primary Outcome Measures :
  1. Cmax [ Time Frame: approximately 15 minutes ]
    maximum observed plasma concentration


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 24 hours ]
    incidence of adverse events

  2. Tmax [ Time Frame: approximately 15 minutes ]
    Time to maximum concentration

  3. t(1/2) [ Time Frame: up to 12 hours ]
    apparent half-life

  4. Visual skin assessment [ Time Frame: 30 minutes, 60 minutes, 12 hours, 24 hours ]
    Scores from an investigator visual skin assessment for erythema, edema, bruising, and bleeding at the patch application sites

  5. Patch adhesion score [ Time Frame: 30 and 60 min ]

    A 5-point numerical scale in which each score corresponds to a specified range of adhered surface area of each patch, as follows: 0 = ≥ 90% adhered (essentially no lift off the skin)

    1. = ≥ 75% to < 90% adhered (some edges only lifting off the skin)
    2. = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin)
    3. = > 0% to < 50% adhered (not detached, but more than half of the patch lifting off the skin without falling off)
    4. = 0% adhered (patch detached; completely off the skin)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  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

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): NCT03708744


Locations
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United States, New Jersey
Hill Top Research, Inc.
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Zosano Pharma Corporation
Investigators
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Study Director: Don Kellerman, Pharm.D. Zosano Pharma Corporation

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Responsible Party: Zosano Pharma Corporation
ClinicalTrials.gov Identifier: NCT03708744     History of Changes
Other Study ID Numbers: CP-2018-002
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 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:
Healthy
Volunteer
Pharmacokinetics
Additional relevant MeSH terms:
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Oxazolidinones
Zolmitriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors