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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zogenix, Inc.
• Treatments: Sumatriptan

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