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A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System

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ClinicalTrials.gov Identifier: NCT00614029
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Zogenix, Inc.

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE February 13, 2008
Last Update Posted Date November 25, 2009
Study Start Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00614029 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System
Official Title  ICMJE 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
Brief Summary A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
Detailed Description 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.)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pharmacokinetics
  • Bioequivalence
Intervention  ICMJE Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Study Arms  ICMJE
  • Experimental: A
    IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh
    Intervention: Device: Sumatriptan (via Intraject System)
  • Experimental: B
    Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh
    Intervention: Device: Sumatriptan (via Intraject System)
  • Experimental: C
    Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm.
    Intervention: Device: Sumatriptan (via Intraject System)
  • Experimental: D
    IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm.
    Intervention: Device: Sumatriptan (via Intraject System)
  • Experimental: E
    IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh
    Intervention: Device: Sumatriptan (via Intraject System)
  • Experimental: F
    Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm
    Intervention: Device: Sumatriptan (via Intraject System)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2008)
54
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00614029
Other Study ID Numbers  ICMJE ZX001-0601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen J. Farr, Ph.D/ President and COO, Zogenix, Inc
Study Sponsor  ICMJE Zogenix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patricia Chandler, MD Covance
PRS Account Zogenix, Inc.
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP