Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00720018
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2008-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2008-07-21', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.\n\nThe secondary objective is to evaluate the safety of NP101 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy Caucasian men or women aged 18 to 45.\n* Subjects have BMI of 18 to 30 kg/m2 inclusive.\n* 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.\n* Subject must have a negative drug screen at screening and on Day -1 for all treatment.\n* Subjects must be nonsmokers, defined as having not used any tobacco products in the 6 months before screening.\n* The subjects will have received no other medication except birth control, for two weeks prior to study entry.\n* Subjects must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or grapefruit juice within 72 hours prior to admission.\n* Female of childbearing potential must have a negative pregnancy test at screening and on Day -1 for all treatment.\n* In the investigator's opinion, the subject must be likely to complete the study.\n* Subjects must be able to communicate effectively and be capable of reading and understanding English and voluntarily sign an IRB approved IC agreement.\n\nExclusion Criteria:\n\n* Subject has a history of allergy or hypersensitivity to any component of the study patch used in this study.\n* Subject has any generalized skin irritation or disease including eczema, psoriasis, melanoma, contact dermatitis or acne.\n* Subject has a tattoo that might interfere with skin irritation examination.\n* Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.\n* Subject has a history of basilar or hemiplegic migraines.\n* Subject has suspected or confirmed cardiovascular disease that contraindicates participation.\n* Subject has Raynaud's disease.\n* Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.\n* Subject with a history of malignancy within the past 5 years.\n* Subject has clinically significant abnormal laboratory parameters, vital signs or ECG parameters.\n* Subject has SGOT/AST, SGPT/ALT, alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal.\n* Subject with a hemoglobin (Hgb) level of less than 7.5 mmol/L.\n* Subject is hepatitis B, hepatitis C or HIV positive.\n* 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.\n* Subject is unwilling to discontinue the use of phosphodiesterase type 5 inhibitor, from screening through the End of Study.\n* 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.\n* Donation of blood or blood products within 8 weeks prior to study entry.\n* Receipt of an investigational drug or participation in any clinical study within 90 days prior to study.\n* Subject who requires any medication on a regular basis, with the exception of steroidal contraceptives.\n* Concurrent use of Rx or OTC medications or natural medicine (herbal) products, with the exception of steroidal contraceptives.\n* 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.\n* Subject who is considered to be an unsuitable candidate for receiving sumatriptan, or as being unsuitable for any other reason.\n* 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)."}, 'identificationModule': {'nctId': 'NCT00720018', 'acronym': 'NP101-006', 'briefTitle': 'Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PROT-15-NP101-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1', 'description': 'NP101 Patch', 'interventionNames': ['Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2', 'description': 'NP101 Patch', 'interventionNames': ['Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Period 3', 'description': 'NP101 Patch', 'interventionNames': ['Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Period 4', 'description': 'NP101 Patch', 'interventionNames': ['Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Period 5', 'description': 'NP101 Patch', 'interventionNames': ['Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch']}], 'interventions': [{'name': 'NP101 Sumatriptan Iontophoretic Transdermal Patch', 'type': 'DRUG', 'description': 'NP101 transdermal patch delivering sumatriptan for 4 hours.', 'armGroupLabels': ['Period 1', 'Period 2', 'Period 3', 'Period 4', 'Period 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Shannon M Canas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prism Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuPathe Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}