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

NCT00720018 | Completed Phase 1

• 1 other identifier: PROT-15-NP101-006
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.

  Blood samples were collected at time points: 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.

Study Arms (5)

Period 1

EXPERIMENTAL

NP101 Patch

Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch

Period 2

EXPERIMENTAL

NP101 Patch

Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch

Period 3

EXPERIMENTAL

NP101 Patch

Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch

Period 4

EXPERIMENTAL

NP101 Patch

Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch

Period 5

EXPERIMENTAL

NP101 Patch

Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch

Interventions

NP101 Sumatriptan Iontophoretic Transdermal Patch DRUG

NP101 transdermal patch delivering sumatriptan for 4 hours.

Period 1; Period 2; Period 3; Period 4; Period 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NuPathe Inc.: lead

Study Sites (1)

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shannon M Canas, MD

  Prism Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 22, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

US (1)