Migraine DisordersPhase 1NP101-006NCT00720018
Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers
A Phase 1 study testing NP101 Sumatriptan Iontophoretic Transdermal Patch in people with Migraine Disorders, run by NuPathe Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- NP101 Sumatriptan Iontophoretic Transdermal Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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 steroidal contraceptives.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- NP101 Sumatriptan Iontophoretic Transdermal Patch
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP101 Sumatriptan Iontophoretic Transdermal PatchDrug
NP101 transdermal patch delivering sumatriptan for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | NP101 Patch Receives: Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch |
| Period 2 | Experimental | NP101 Patch Receives: Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch |
| Period 3 | Experimental | NP101 Patch Receives: Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch |
| Period 4 | Experimental | NP101 Patch Receives: Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch |
| Period 5 | Experimental | NP101 Patch Receives: Drug: NP101 Sumatriptan Iontophoretic Transdermal Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuPathe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shannon M Canas, MD, Principal investigator, Prism Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720018
- Sponsor's protocol ID
- PROT-15-NP101-006
- Acronym
- NP101-006
- Status last verified
- Feb 2016
- First submitted
- 21 Jul 2008
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00720018
- Acronym / sponsor ID
- NP101-006 / PROT-15-NP101-006
- Conditions
- Migraine Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NuPathe Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: NP101 Sumatriptan Iontophoretic Transdermal PatchNP101 Patch |
| Period 2 | Experimental | Drug: NP101 Sumatriptan Iontophoretic Transdermal PatchNP101 Patch |
| Period 3 | Experimental | Drug: NP101 Sumatriptan Iontophoretic Transdermal PatchNP101 Patch |
| Period 4 | Experimental | Drug: NP101 Sumatriptan Iontophoretic Transdermal PatchNP101 Patch |
| Period 5 | Experimental | Drug: NP101 Sumatriptan Iontophoretic Transdermal PatchNP101 Patch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP101 Sumatriptan Iontophoretic Transdermal PatchNP101 transdermal patch delivering sumatriptan for 4 hours. | Drug | Period 1, Period 2, Period 3, Period 4, Period 5 |
Primary outcome
The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon M Canas, MD principal investigator
Prism Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NP101 Sumatriptan Iontophoretic Transdermal Patch in people with Migraine Disorders, run by NuPathe Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.