HealthyPhase 1NCT00546650
Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®
A Phase 1 study testing Sumatriptan succinate in people with Healthy, run by NuPathe Inc. at 1 site in United States.
Trial summary
The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sumatriptan succinate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men or women aged 18 to 65 years.
- Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the study, and must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 for all periods.
- Subjects must have body mass index (BMI) of 18 to 30 kg/m2 inclusive.
- Subjects must be able to communicate effectively with the study personnel.
- Subjects must have, in the investigator's opinion, no clinically significant disease or abnormal laboratory values as determined by medical and psychiatric history, physical examination, or laboratory evaluations conducted at the screening visit or on clinic admission.
- Subjects must have a 12-lead ECG without any clinically significant abnormalities of rate, rhythm, intervals or conduction, as determined by the investigator.
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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
- Female subjects who are pregnant or breast feeding or planning a pregnancy during the study.
- A known hypersensitivity to sumatriptan or other triptan agents or the recipients of any of the formulations.
- Subject currently has hypertension with blood pressure outside of normal range for age group.
- Subject has hemiplegic or basilar migraine.
- Subject has severe hepatic impairment.
- Subject has any skin irritation or disease that might interfere with absorption of study drug or skin irritation assessment, including eczema, psoriasis, melanoma, or acne.
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- Subject has a tattoo that might interfere with skin erythema examination.
- Subject has a positive test result for hepatitis B, or C or is known to be HIV positive or have a medical history of AIDS.
- 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.
- Subject who requires any medication on a regular basis.
- Subject with a history of malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- Subject with a hemoglobin (Hgb) level of less than 7.5 mmol/L.
- Subject has a history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes.
- Recent (within one year of screening) history of alcohol abuse, illicit drug use, physical dependence to any opioid, or recent (within one year of screening) history of drug abuse or addiction.
- Concurrent use of prescription (Rx) or over-the-counter (OTC) medications or natural medicine (herbal) products.
- Subject is currently taking MAO-A inhibitors
- Receipt of an investigational drug or participation in any clinical study within 90 days prior to study entry.
- Donation of blood or blood products within 8 weeks prior to study entry.
- Positive urine drug screen, including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
- Subject who is considered by the investigator or NuPathe, for any reason, to be an unsuitable candidate for receiving sumatriptan, or as being unsuitable for any other reason as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase I, Single Center, Open Label, Randomized, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® in Healthy Volunteers
The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Sumatriptan succinate
- Keywords
- Focus of study is to compare pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan succinateDrug
NP101 iontophoretic transdermal system
Sumatriptan succinateDrug
oral, subcutaneous, and intranasal formulations
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | NP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver ~ 10 mg of sumatriptan utilizing up to 600 mA minutes. Receives: Drug: Sumatriptan succinate |
| B | Active comparator | Sumatriptan succinate (Imitrex®) tablet: 100 mg orally. Receives: Drug: Sumatriptan succinate |
| C | Active comparator | Sumatriptan succinate (Imitrex®) injection: 6 mg subcutaneously (SQ). Receives: Drug: Sumatriptan succinate |
| D | Active comparator | Sumatriptan (Imitrex®) nasal spray: 20 mg (one spray) intranasal (IN) into one nostril. Receives: Drug: Sumatriptan succinate |
| E | Experimental | NP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver ~ 10 mg of sumatriptan utilizing up to 600 mA minutes. Receives: Drug: Sumatriptan succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
The primary objective was to compare the pharmacokinetics (PK) of NP101 (sumatriptan iontophoretic transdermal patch) with the currently approved oral, subcutaneous injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection.
Measured: Blood samples to be drawn at 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 posted19 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuPathe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas C Marbury, MD, Principal investigator, Orlando Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546650
- Sponsor's protocol ID
- NP101-005
- Status last verified
- Feb 2016
- First submitted
- 17 Oct 2007
- 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, Randomized, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00546650
- Acronym / sponsor ID
- NP101-005
- Conditions
- Healthy
- Keywords
- Focus of study is to compare pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NuPathe Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Oct 2007 (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) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Sumatriptan succinateNP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver ~ 10 mg of sumatriptan utilizing up to 600 mA minutes. |
| B | Active comparator | Drug: Sumatriptan succinateSumatriptan succinate (Imitrex®) tablet: 100 mg orally. |
| C | Active comparator | Drug: Sumatriptan succinateSumatriptan succinate (Imitrex®) injection: 6 mg subcutaneously (SQ). |
| D | Active comparator | Drug: Sumatriptan succinateSumatriptan (Imitrex®) nasal spray: 20 mg (one spray) intranasal (IN) into one nostril. |
| E | Experimental | Drug: Sumatriptan succinateNP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver ~ 10 mg of sumatriptan utilizing up to 600 mA minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy men or women aged 18 to 65 years.
- Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the study, and must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 for all periods.
- Subjects must have body mass index (BMI) of 18 to 30 kg/m2 inclusive.
- Subjects must be able to communicate effectively with the study personnel.
- Subjects must have, in the investigator's opinion, no clinically significant disease or abnormal laboratory values as determined by medical and psychiatric history, physical examination, or laboratory evaluations conducted at the screening visit or on clinic admission.
Key exclusion criteria (20 listed)
- Female subjects who are pregnant or breast feeding or planning a pregnancy during the study.
- A known hypersensitivity to sumatriptan or other triptan agents or the recipients of any of the formulations.
- Subject currently has hypertension with blood pressure outside of normal range for age group.
- Subject has hemiplegic or basilar migraine.
- Subject has severe hepatic impairment.
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 |
|---|---|---|
| Sumatriptan succinateNP101 iontophoretic transdermal system | Drug | A, E |
| Sumatriptan succinateoral, subcutaneous, and intranasal formulations | Drug | B, C, D |
Primary outcome
Pharmacokinetics
Time frame: Blood samples to be drawn at 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.
The primary objective was to compare the pharmacokinetics (PK) of NP101 (sumatriptan iontophoretic transdermal patch) with the currently approved oral, subcutaneous injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection.
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.
Thomas C Marbury, MD principal investigator
Orlando Clinical Research Center
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 Sumatriptan succinate in people with Healthy, 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 20 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?
Pharmacokinetics (time frame: Blood samples to be drawn at 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.