Status:
COMPLETED
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
Lead Sponsor:
Zogenix, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. Assess...
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 admi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00620425
Start Date
December 1 2007
End Date
December 1 2007
Last Update
May 9 2023
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