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

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 Overview

• Status: Completed
• Conditions: Pharmacokinetics; Bioequivalence
• Intervention / Treatment: Device: Sumatriptan (via 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: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	one week

Collaborators and Investigators

• Sponsor: Zogenix, Inc.
• Investigators: Principal Investigator: Patricia Chandler, MD, Covance

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: February 12, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Subcutaneous; Injections; sumatriptan
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Sumatriptan
• Other Study ID Numbers: ZX001-0601