PharmacokineticsPhase 1NCT00614029
A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System
A Phase 1 study testing Sumatriptan (via Intraject System) in people with Pharmacokinetics and Bioequivalence, run by Zogenix, Inc. at 1 site in United States.
Trial summary
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Bioequivalence
- What is being tested?
- Sumatriptan (via Intraject System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2006
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Negative serum pregnancy test
- Female subjects of child-bearing potential must agree to use acceptable birth control 3 weeks prior to and 2 weeks after study dosing.
- Body Mass Index (BMI) and sufficient subcutaneous thickness, in the opinion of the investigator, for an injection into the abdomen, arm and thigh
- Non-tobacco user
- Adequate venous access in the left or right arm to allow collection of a number of blood samples
- Fluent in the English language
- Provide written informed consent to participate in the study and be willing to comply with the study procedures
Who cannot join
- History within the previous 2 years of drug or alcohol dependence
- Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
- History of epilepsy or other neurologic disease
- History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension, or signs/symptoms of ischemic heart disease
- History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or similar drugs including sulphonamides
- History of scleroderma or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
Show all 10Show fewer
- Tattoos or birthmarks in the lateral thigh, abdominal area or arm (deltoid) that are large enough to restrict injection site selection and/or evaluation
- Positive screening test for HIV antibodies, Hepatitis B surface antigen, or Hepatitis C antibody
- Positive results on illicit drug test at Screening or at Check-in
- Use of any prescription medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose, Four-way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Versus IMITREX STATdose at Three Injection Sites in Healthy Adults
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
Read the detailed description
A single center, randomized, single-dose, open-label, partial-block, four-period, four-way crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)
- Conditions
- Pharmacokinetics, Bioequivalence
- Being tested
- Sumatriptan (via Intraject System)
- Keywords
- sumatriptan, Injections, Subcutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan (via Intraject System)Device
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh Receives: Device: Sumatriptan (via Intraject System) |
| B | Experimental | Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh Receives: Device: Sumatriptan (via Intraject System) |
| C | Experimental | Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm. Receives: Device: Sumatriptan (via Intraject System) |
| D | Experimental | IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm. Receives: Device: Sumatriptan (via Intraject System) |
| E | Experimental | IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh Receives: Device: Sumatriptan (via Intraject System) |
| F | Experimental | Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm Receives: Device: Sumatriptan (via Intraject System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve, maximal plasma concentration, time to maximal concentration, terminal elimination half-life, and apparent terminal elimination rate constant of sumatriptan will be determined at each of 3 sites
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patricia Chandler, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614029
- Sponsor's protocol ID
- ZX001-0601
- Status last verified
- Nov 2009
- First submitted
- 7 Jan 2008
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, Four-way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Versus IMITREX STATdose at Three Injection Sites in Healthy Adults
- ClinicalTrials.gov ID
- NCT00614029
- Acronym / sponsor ID
- ZX001-0601
- Conditions
- Pharmacokinetics, Bioequivalence
- Keywords
- sumatriptan, Injections, Subcutaneous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 13 Feb 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.
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
Detailed description
A single center, randomized, single-dose, open-label, partial-block, four-period, four-way crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Sumatriptan (via Intraject System)IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh |
| B | Experimental | Device: Sumatriptan (via Intraject System)Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh |
| C | Experimental | Device: Sumatriptan (via Intraject System)Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm. |
| D | Experimental | Device: Sumatriptan (via Intraject System)IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm. |
| E | Experimental | Device: Sumatriptan (via Intraject System)IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh |
| F | Experimental | Device: Sumatriptan (via Intraject System)Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy subjects
- Negative serum pregnancy test
- Female subjects of child-bearing potential must agree to use acceptable birth control 3 weeks prior to and 2 weeks after study dosing.
- Body Mass Index (BMI) and sufficient subcutaneous thickness, in the opinion of the investigator, for an injection into the abdomen, arm and thigh
- Non-tobacco user
Key exclusion criteria (10 listed)
- History within the previous 2 years of drug or alcohol dependence
- Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
- History of epilepsy or other neurologic disease
- History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension, or signs/symptoms of ischemic heart disease
- History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or similar drugs including sulphonamides
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 (via Intraject System)0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt | Device | A, B, C, D, E, F |
Primary outcome
The area under the plasma concentration-time curve, maximal plasma concentration, time to maximal concentration, terminal elimination half-life, and apparent terminal elimination rate constant of sumatriptan will be determined at each of 3 sites
Time frame: one week
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 10 Nov 2022.
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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.
Patricia Chandler, MD principal investigator
Covance
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 (via Intraject System) in people with Pharmacokinetics and Bioequivalence, run by Zogenix, 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 8 inclusion and 10 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 10 Nov 2022. 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 area under the plasma concentration-time curve, maximal plasma concentration, time to maximal concentration, terminal elimination half-life, and apparent terminal elimination rate constant of sumatriptan will be determined at each of 3 sites (time frame: one week). 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 10 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.