A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System - Full Text View

Sponsored by:	Zogenix, Inc.
Information provided by:	Zogenix, Inc.
ClinicalTrials.gov Identifier:	NCT00614029

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 I

Drug Information available for: Succinic acid Sodium chloride Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Sumatriptan succinate Sumatriptan

U.S. FDA Resources

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

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
A: Experimental 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
B: Experimental 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
C: Experimental 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
D: Experimental 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
E: Experimental 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
F: Experimental 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

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 Inc.

More Information

Responsible Party:	Zogenix, Inc ( Stephen J. Farr, Ph.D/ President and COO )
Study ID Numbers:	ZX001-0601
Study First Received:	January 7, 2008
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00614029
Health Authority:	United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:

sumatriptan
Injections
Subcutaneous

Study placed in the following topic categories:

Sumatriptan
Naphazoline
Oxymetazoline
Guaifenesin

Phenylephrine
Phenylpropanolamine
Healthy
Serotonin

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009