A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Sumatriptan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sumatriptan|injection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days. | -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sumatriptan, Intraject, Local Site Reactions