Trial Search Results

A Study of M207 With Intranasal Zolmitriptan 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Zosano Pharma Corporation

Stanford Investigator(s):

Intervention(s):

  • Drug: A: M207 3.8mg, 30 min, upper arm
  • Drug: B: M207 3.8 mg, 30 min, thigh
  • Drug: C: M207 3.8 mg, 1 hr, upper arm
  • Drug: D:zolmitriptan nasal spray

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - 50 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting