Expired Study
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Dallas, Texas 75247


Purpose:

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


Study summary:

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.)


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


Study is Available At:


Original ID:

ZX001-0601


NCT ID:

NCT00614029


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Zogenix, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

54


Enrollment Type:

Actual


Overall Contact Information

Official Name:Patricia Chandler, MD
Principal Investigator
Covance

Study Dates

Start Date:December 2006
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:November 2009
Last Changed Date:November 23, 2009
First Received Date:January 7, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Sumatriptan (via Intraject System)
Description:0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Arm Name:A

Study Arms

Study Arm Type:Experimental
Arm Name:F
Description:Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm
Study Arm Type:Experimental
Arm Name:E
Description:IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh
Study Arm Type:Experimental
Arm Name:D
Description:IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm.
Study Arm Type:Experimental
Arm Name:C
Description:Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm.
Study Arm Type:Experimental
Arm Name:B
Description:Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh
Study Arm Type:Experimental
Arm Name:A
Description:IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Zogenix, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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