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

This study has been completed.
Sponsor:
Information provided by:
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT00614029
First received: January 7, 2008
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Bioequivalence
Device: Sumatriptan (via Intraject System)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Experimental: B
Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Experimental: C
Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm.
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Experimental: D
IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm.
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Experimental: E
IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Experimental: F
Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

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.)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614029

Locations
United States, Texas
Covance, Inc
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Zogenix, Inc.
Investigators
Principal Investigator: Patricia Chandler, MD Covance
  More Information

No publications provided

Responsible Party: Stephen J. Farr, Ph.D/ President and COO, Zogenix, Inc
ClinicalTrials.gov Identifier: NCT00614029     History of Changes
Other Study ID Numbers: ZX001-0601
Study First Received: January 7, 2008
Last Updated: November 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:
sumatriptan
Injections
Subcutaneous

Additional relevant MeSH terms:
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014