Official Title: “A Randomized, Open-Label, Single-Dose, Four-Way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Versus IMITREX STATdose at Three Injection Sites in Healthy Adults”

A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.

Study Type: Interventional

Study Design: Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: December 2006

A single center, randomized, single-dose, open-label, partial-block, four-period, four-way crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)

Intervention(s) in this Clinical Trial

• Device: Sumatriptan (via Intraject System)
  • 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh
• Experimental: B
  • Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh
• Experimental: C
  • Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm.
• Experimental: D
  • IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm.
• Experimental: E
  • IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh
• Experimental: F
  • Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm

Primary Measures

• The area under the plasma concentration-time curve, maximal plasma concentration, time to maximal concentration, terminal elimination half-life, and apparent terminal elimination rate constant of sumatriptan will be determined at each of 3 sites
  • Time Frame: one week
    Safety Issue?: No

Inclusion Criteria:

• Healthy subjects
• Negative serum pregnancy test
• Female subjects of child-bearing potential must agree to use acceptable birth control 3 weeks prior to and 2 weeks after study dosing.
• Body Mass Index (BMI) and sufficient subcutaneous thickness, in the opinion of the investigator, for an injection into the abdomen, arm and thigh
• Non-tobacco user
• Adequate venous access in the left or right arm to allow collection of a number of blood samples
• Fluent in the English language
• Provide written informed consent to participate in the study and be willing to comply with the study procedures

Exclusion Criteria:

• History within the previous 2 years of drug or alcohol dependence
• Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
• History of epilepsy or other neurologic disease
• History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension, or signs/symptoms of ischemic heart disease
• History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or similar drugs including sulphonamides
• History of scleroderma or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
• Tattoos or birthmarks in the lateral thigh, abdominal area or arm (deltoid) that are large enough to restrict injection site selection and/or evaluation
• Positive screening test for HIV antibodies, Hepatitis B surface antigen, or Hepatitis
• C antibody
• Positive results on illicit drug test at Screening or at Check-in
• Use of any prescription medication

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Zogenix, Inc.

Overall Clinical Trial Officials and Contacts

Patricia Chandler, MD Principal Investigator Covance, Inc.  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00614029

Study ID Number: ZX001-0601

ClinicalTrials.gov Identifier: NCT00614029

Health Authority: United States: Food and Drug Administration