The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101
patches in healthy volunteers.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
- 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
- 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.
- 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
- Subject has a history of basilar or hemiplegic migraines.
- Subject has suspected or confirmed cardiovascular disease that contraindicates
- Subject has Raynaud's disease.
- Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or
- Subject with a history of malignancy within the past 5 years.
- Subject has clinically significant abnormal laboratory parameters, vital signs or ECG
- 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
- 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).