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

NCT ID: NCT00620425

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2007-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Sumatriptan

injection

Intervention Type: DRUG

Other Intervention Names

SUMAVEL(R) DosePro(R)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zogenix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Chandler, MD

Role: PRINCIPAL_INVESTIGATOR

Covance

Other Identifiers

ZX001-0703

Identifier Type: -

Identifier Source: org_study_id