CompletedPhase 1

Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®

United States25 participantsStarted 2007-11

Plain-language summary

The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. The secondary objective is to evaluate the safety of NP101 in healthy volunteers.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy men or women aged 18 to 65 years. * Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the study, and must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 for all periods. * Subjects must have body mass index (BMI) of 18 to 30 kg/m2 inclusive. * Subjects must be able to communicate effectively with the study personnel. * Subjects must have, in the investigator's opinion, no clinically significant disease or abnormal laboratory values as determined by medical and psychiatric history, physical examination, or laboratory evaluations conducted at the screening visit or on clinic admission. * Subjects must have a 12-lead ECG without any clinically significant abnormalities of rate, rhythm, intervals or conduction, as determined by the investigator. * Subjects must be nonsmokers, defined as having not used any tobacco products in the 6 months before screening. * Subjects must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or grapefruit juice within 72 hours prior to admission to the clinic for Period 1 and for the duration of the study. * Subjects must be adequately informed of the nature and risks of the study and give written informed consent prior to screening. * The subject must be likely to complete the entire study. Exclusion Criteria: * Female subjects who are pregnant or breast feeding or planning a pregnancy durin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics

Timeframe: Blood samples to be drawn at pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 16 hrs post dose.

Trial details

NCT IDNCT00546650

SponsorNuPathe Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

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