A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
Information source: Zogenix, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Phase: N/A
Status: Completed
Sponsored by: Zogenix, Inc.
Summary
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled
with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections
over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
Clinical Details
Official title: A Single-Center, Open-Label, Single-Arm Study to Evaluate the Effects of Repeat Doses of Subcutaneously Delivered Sumatriptan Via the Intraject System of Local Injection Site Signs in Healthy Adult Subjects.
Study design: Cohort, Prospective
Primary outcome: To evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of Intraject sumatriptan to the same anatomic site.
Detailed description:
This study will evaluate the extent, persistence, and any cumulative effects on skin tissue
by assessing local injection site reactions (bleeding, swelling, erythema, bruising)
following repeated administrations of needle-free Intraject sumatriptan to the same anatomic
site.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Female subjects of child-bearing potential must agree to use acceptable birth control
- Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for
needle-free injection
- Fluent in the spoken and written English language
- Provide written informed consent to participate in the study and be willing to comply
with the study procedures
- Non-tobacco user for at least 12 months prior to screening (all types of tobacco,
including cigars)
Exclusion Criteria:
- A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral
vascular syndromes including ischemic or vasospastic coronary artery disease
- Other significant underlying cardiovascular diseases including uncontrolled
hypertension
- Hemiplegic or basilar migraine
- A history or diagnosis of severe hepatic or renal impairment
- A history of epilepsy or seizure or other serious neurologic condition
- A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its
components or similar drugs
- A history of scleroderma (systemic sclerosis) or any skin condition that may adversely
affect the injection or absorption of subcutaneously administered medications
- Tattoos, birthmarks or other significant skin discoloration in the thigh or abdominal
area that are large enough to restrict injection site selection and/or evaluation
- Pregnancy or breast-feeding
- Have participated in a clinical trial or receipt of an experimental therapy within 30
days prior to dosing
Locations and Contacts
Additional Information
Starting date: December 2007
Ending date: December 2007
Last updated: February 20, 2008
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