Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers (NP101-006)

This is an interventional treatment trial for Migraine Disorders Read More

Inclusion Criteria:

• Healthy Caucasian men or women aged 18 to 45.
• Subjects have BMI of 18 to 30 kg/m2 inclusive.
• Subject judged to be in good health, based upon the results of a medical history, physical examination, vital signs, ECG and laboratory profile. Subjects will not have any clinically significant abnormal findings in order to qualify for enrollment.
• Subject must have a negative drug screen at screening and on Day -1 for all treatment.
• Subjects must be nonsmokers, defined as having not used any tobacco products in the 6 months before screening.
• The subjects will have received no other medication except birth control, for two weeks prior to study entry.
• Subjects must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or grapefruit juice within 72 hours prior to admission.
• Female of childbearing potential must have a negative pregnancy test at screening and on Day -1 for all treatment.
• In the investigator's opinion, the subject must be likely to complete the study.
• Subjects must be able to communicate effectively and be capable of reading and understanding English and voluntarily sign an IRB approved IC agreement.

Exclusion Criteria:

• Subject has a history of allergy or hypersensitivity to any component of the study patch used in this study.
• Subject has any generalized skin irritation or disease including eczema, psoriasis, melanoma, contact dermatitis or acne.
• Subject has a tattoo that might interfere with skin irritation examination.
• Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
• Subject has a history of basilar or hemiplegic migraines.
• Subject has suspected or confirmed cardiovascular disease that contraindicates participation.
• Subject has Raynaud's disease.
• Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.
• Subject with a history of malignancy within the past 5 years.
• Subject has clinically significant abnormal laboratory parameters, vital signs or ECG parameters.
• Subject has SGOT/AST, SGPT/ALT, alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal.
• Subject with a hemoglobin (Hgb) level of less than 7.5 mmol/L.
• Subject is hepatitis B, hepatitis C or HIV positive.
• Subject has taken an MAO inhibitor, preparations containing St. John's Wort, SSRI, SNRI, TCA, triptan or ergot medication, within one month prior to screening.
• Subject is unwilling to discontinue the use of phosphodiesterase type 5 inhibitor, from screening through the End of Study.
• Subject who has been administered an injectable drug, except for local anesthetic or birth control, within 30 days prior to the initial study drug administration.
• Donation of blood or blood products within 8 weeks prior to study entry.
• Receipt of an investigational drug or participation in any clinical study within 90 days prior to study.
• Subject who requires any medication on a regular basis, with the exception of steroidal contraceptives.
• Concurrent use of Rx or OTC medications or natural medicine (herbal) products, with the exception of steroidal contraceptives.
• Female subject who is pregnant, planning a pregnancy during the study, breast feeding; or if of childbearing potential, not using or unwilling to use an effective form of contraception during the study and for a period of 30 days following dosing.
• Subject who is considered to be an unsuitable candidate for receiving sumatriptan, or as being unsuitable for any other reason.
• Subject is electrically sensitive (e.g., prior iontophoresis with adverse outcome related to the current delivered by the device) or who have an implantable electronic device (e.g., pacemaker).