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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- Zosano Pharma Corporation
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women or men 18 to 50 years of age.
- •Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count (CBC), blood chemistry, urinalysis, and ECG.
- •Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening.
- •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).
- •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
- •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 two or more risk factors for cardiovascular disease (family history of premature heart disease, hyperlipidemia, or hypertension)
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Adverse Events(24 hours)
- t(1/2)(pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose)