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

Phase 1

Completed

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. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.

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.

Recruitment & Eligibility

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

Primary Outcome Measures

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

Secondary Outcome Measures