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COMPLETEDPHASE1

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

A Phase I, Single Center, Open Label, Single-Dose, Five-Period Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) in Healthy Volunteers

NCT00720018•NuPathe Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.
+13 more criteria

Locations (1)

Prism Research

Saint Paul, Minnesota, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

February 3, 2016

Enrollment

ACTUAL participants

Conditions

Migraine Disorders

Interventions

NP101 Sumatriptan Iontophoretic Transdermal Patch

DRUG

Mind Body Balance for Pediatric Migraine

NCT04715685

HeadacheHeadache Disorders+6 more

View study

RECRUITING

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

NCT05570149

Migraine Disorders

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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