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

Zogenix

Status and phase: Completed; Phase 1

Conditions: Bioequivalence; Pharmacokinetics

Treatments: Device: Sumatriptan (via Intraject System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00614029

ZX001-0601

Details and patient eligibility

About

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

Full 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.)

Enrollment: 54 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 6 patient groups

A

Experimental group

Description:

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

Treatment:

Device: Sumatriptan (via Intraject System)

B

Experimental group

Description:

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

Treatment:

Device: Sumatriptan (via Intraject System)

C

Experimental group

Description:

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

Treatment:

Device: Sumatriptan (via Intraject System)

D

Experimental group

Description:

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

Treatment:

Device: Sumatriptan (via Intraject System)

E

Experimental group

Description:

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

Treatment:

Device: Sumatriptan (via Intraject System)

F

Experimental group

Description:

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

Treatment:

Device: Sumatriptan (via Intraject System)