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

NCT ID: NCT00614029

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

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.)

Conditions

Pharmacokinetics; Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh

Group Type: EXPERIMENTAL

Sumatriptan (via Intraject System)

Intervention Type: DEVICE

0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

B

Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh

Group Type: EXPERIMENTAL

Sumatriptan (via Intraject System)

Intervention Type: DEVICE

0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

C

Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm.

Group Type: EXPERIMENTAL

Sumatriptan (via Intraject System)

Intervention Type: DEVICE

0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

D

IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm.

Group Type: EXPERIMENTAL

Sumatriptan (via Intraject System)

Intervention Type: DEVICE

0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

E

IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh

Group Type: EXPERIMENTAL

Sumatriptan (via Intraject System)

Intervention Type: DEVICE

0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

F

Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm

Group Type: EXPERIMENTAL

Sumatriptan (via Intraject System)

Intervention Type: DEVICE

0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

Interventions

Sumatriptan (via Intraject System)

0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zogenix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Zogenix, Inc

Principal Investigators

Patricia Chandler, MD

Role: PRINCIPAL_INVESTIGATOR

Covance

Locations

Covance, Inc

Dallas, Texas, United States

Countries

United States

Other Identifiers

ZX001-0601

Identifier Type: -

Identifier Source: org_study_id