Compare Bioequivalence Patches Previously Used in the NP101-007 StudyPhase 1NCT01381796
Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults
A Phase 1 study testing NP101 and sumatriptan succinate in people with Compare Bioequivalence Patches Previously Used in the NP101-007 Study, run by NuPathe Inc. at 1 site in United States.
Trial summary
The purpose of this research is to: 1. Compare two study patches having minor differences in patch components 2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates medication) of NP101 (study patches) versus a currently approved oral formulation of Imitrex 3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Compare Bioequivalence Patches Previously Used in the NP101-007 Study
- What is being tested?
- NP101 and sumatriptan succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male and female subjects, between the ages of 18 to 65 years, at the time of screening.
- Subject judged to be in good health, base upon result of medical history, physical examination, vital signs, ECG and laboratory profile. Subjects will not have any clinically significant abnormal laboratory parameters, vital signs or ECG parameters in order to qualify for enrollment.
- Subject must be capable of reading and understanding English or Spanish, and be able to carry-out all study procedures, and voluntarily sign and date an informed consent (IC) agreement approved by an IRB.
- Subject must have a negative drug screen.
- Subject has two acceptable patch application sites (left and/or right upper arms) that is relatively hair free and has no scars, tattoos, scratches or bruises.
- Subjects must have body mass index of 18 to 25 kg/m2 inclusive.
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- 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.
Who cannot join
- Subject has suspected or confirmed cardiovascular disease that contraindicates study participation.
- Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
- Subject with Raynaud's disease.
- Subject has a history of basilar or hemiplegic migraines.
- Subject has a current diagnosis of a major depressive disorder per the Diagnostic and Statistical Manual of Mental Disorders version 4 revised (DSM-IV-R).
- Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs, including Wellbutrin), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs) or preparations containing St. Joh's Wort within 1 month prior to screening and/or is planning to start any of these medications during the study and through the End of Study visit.
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- Subject is unwilling to discontinue use of a phosphodiesterase type 5 inhibitor (e.g. Viagra, Levitra, or Cialis) from screening through the End of Study visit.
- Subject with a history of a significant allergy or hypersensitivity to any component of the study patch used in this study (NP101 formulation details can be found in the NP101 Investigator Brochure).
- Subject who has any generalized skin irritation or disease including eczema, psoriasis, melanoma, acne or contact dermatitis.
- Subject is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Subject has hepatic dysfunction defined as SGOT/AST or SGPT/ALT greater than or equal to 2 times the upper limit of normal (ULN)range, or alkaline phosphatase or total bilirubin greater than or equal to 1.5 times the ULN range or if in the opinion of the Investigator the subject's history, physical examination or other laboratory tests suggest hepatic dysfunction.
- Female subjects who are pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception during the study and for a period of 30 days following final dosing. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If the exclusive male partner is surgically sterile, this will be acceptable.
- Subject has known history of tolerability issues with sumatriptan.
- Subject who is considered by investigator or NuPathe, for any reason, to be an unsuitable candidate for this study.
- Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.
- Subject has participated in a clinical study within 30 days of screening.
- Subject has clinically significant abnormal laboratory parameters, vial signs or ECG parameters.
- 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, Randomized, Single-Dose, Three-Way Crossover Study to Compare the Pharmacokinetics and Bioavailability of Two NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex in Healthy Volunteers and to Collect Resistance Data During Application of NP101
The purpose of this research is to:
- Compare two study patches having minor differences in patch components
- Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates medication) of NP101 (study patches) versus a currently approved oral formulation of Imitrex
- Collect resistance data during application of NP101 (study patch)
- Being tested
- NP101, sumatriptan succinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP101Drug
comparison of NP101 with minor patch modifications
sumatriptan succinateDrug
Also called Imitrex
tablet, 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - NP101 | Active comparator | Not described Receives: Drug: NP101 |
| Treatment C - oral sumatriptan succinate | Active comparator | Not described Receives: Drug: sumatriptan succinate |
| Treatment B - NP101B | Experimental | Not described Receives: Drug: NP101 |
| Treatment D - NP101D | Experimental | Not described Receives: Drug: NP101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of variance (ANOVA) will be used to compare AUC0-inf and Cmax values between treatments. AUC0-last, Tmax and t1/2 will be summarized descriptively.
Blood samples (4 mL per sample) for PK analysis will be collected at the following times for the determination of sumatriptan concentrations in plasma for each treatment:
Pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post-dose.
Measured: Blood samples (4 mL per sample) for PK analysis will be collected for all treatments by catheter or venipuncture into EDTA collection tubes for the determination of sumatriptan concentrations in plasma for each treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Bioequivalence Patches Previously Used in the NP101-007 StudyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuPathe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shannon Canas, MD, Principal investigator, Prism Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381796
- Sponsor's protocol ID
- PROT-15-NP101-013
- Status last verified
- Oct 2017
- First submitted
- 22 Jun 2011
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Open Label, Randomized, Single-Dose, Three-Way Crossover Study to Compare the Pharmacokinetics and Bioavailability of Two NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex in Healthy Volunteers and to Collect Resistance Data During Application of NP101
- ClinicalTrials.gov ID
- NCT01381796
- Acronym / sponsor ID
- PROT-15-NP101-013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- NuPathe Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Jun 2011 (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 purpose of this research is to:
- Compare two study patches having minor differences in patch components
- Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates medication) of NP101 (study patches) versus a currently approved oral formulation of Imitrex
- Collect resistance data during application of NP101 (study patch)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A - NP101 | Active comparator | Drug: NP101 |
| Treatment C - oral sumatriptan succinate | Active comparator | Drug: sumatriptan succinate |
| Treatment B - NP101B | Experimental | Drug: NP101 |
| Treatment D - NP101D | Experimental | Drug: NP101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy adult male and female subjects, between the ages of 18 to 65 years, at the time of screening.
- Subject judged to be in good health, base upon result of medical history, physical examination, vital signs, ECG and laboratory profile. Subjects will not have any clinically significant abnormal laboratory parameters, vital signs or ECG parameters in order to qualify for enrollment.
- Subject must be capable of reading and understanding English or Spanish, and be able to carry-out all study procedures, and voluntarily sign and date an informed consent (IC) agreement approved by an IRB.
- Subject must have a negative drug screen.
- Subject has two acceptable patch application sites (left and/or right upper arms) that is relatively hair free and has no scars, tattoos, scratches or bruises.
Key exclusion criteria (18 listed)
- Subject has suspected or confirmed cardiovascular disease that contraindicates study participation.
- Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
- Subject with Raynaud's disease.
- Subject has a history of basilar or hemiplegic migraines.
- Subject has a current diagnosis of a major depressive disorder per the Diagnostic and Statistical Manual of Mental Disorders version 4 revised (DSM-IV-R).
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 |
|---|---|---|
| NP101comparison of NP101 with minor patch modifications | Drug | Treatment A - NP101, Treatment B - NP101B, Treatment D - NP101D |
| sumatriptan succinateAlso: Imitrextablet, 100 mg | Drug | Treatment C - oral sumatriptan succinate |
Primary outcome
Analysis of variance (ANOVA) will be used to compare AUC0-inf and Cmax values between treatments. AUC0-last, Tmax and t1/2 will be summarized descriptively.
Time frame: Blood samples (4 mL per sample) for PK analysis will be collected for all treatments by catheter or venipuncture into EDTA collection tubes for the determination of sumatriptan concentrations in plasma for each treatment.
Blood samples (4 mL per sample) for PK analysis will be collected at the following times for the determination of sumatriptan concentrations in plasma for each treatment: Pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 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 12 Oct 2017.
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 Canas, MD principal investigator
Prism Research LLC
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 and sumatriptan succinate in people with Compare Bioequivalence Patches Previously Used in the NP101-007 Study, 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 18 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 12 Oct 2017. 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?
Analysis of variance (ANOVA) will be used to compare AUC0-inf and Cmax values between treatments. AUC0-last, Tmax and t1/2 will be summarized descriptively. (time frame: Blood samples (4 mL per sample) for PK analysis will be collected for all treatments by catheter or venipuncture into EDTA collection tubes for the determination of sumatriptan concentrations in plasma for each treatment.). 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 12 Oct 2017.