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

NCT00620425 | Completed Phase 1 Results DMC

• 1 other identifier: ZX001-0703
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

sumatriptan; Intraject; Local Site Reactions

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Sumatriptan DRUG

injection

Also known as: SUMAVEL(R) DosePro(R)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zogenix, Inc.: lead

MeSH Terms

Interventions

Sumatriptan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Edward Smith III, PhD, VP Regulatory Affairs & Product Quality/Safety
• Organization: Zogenix, Inc

esmith@zogenix.com

510 550 8325

Study Officials

• Patricia Chandler, MD

  Covance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: February 21, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 9, 2023
• Results First Posted: July 17, 2012

Record last verified: 2023-05