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

Phase 1

Completed

• Conditions: Pharmacokinetics; Bioequivalence
• Interventions: Device: Sumatriptan (via Intraject System)

• Registration Number: NCT00614029
• Lead Sponsor: Zogenix, Inc.

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 Timeline

• Study Start: 2006-12
• Primary Completion: 2006-12
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Status Verified: 2009-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Sumatriptan (via Intraject System)	IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh
C	Sumatriptan (via Intraject System)	Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm.
F	Sumatriptan (via Intraject System)	Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm
D	Sumatriptan (via Intraject System)	IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm.
E	Sumatriptan (via Intraject System)	IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh
B	Sumatriptan (via Intraject System)	Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Covance, Inc; 🇺🇸 Dallas, Texas, United States