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.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Zogenix, Inc.
- Enrollment
- 18
- Primary Endpoint
- The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Time Frame: -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 Outcomes
No secondary outcomes reported