NCT00614029

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2009

Enrollment Period

Same day

First QC Date

January 7, 2008

Last Update Submit

November 8, 2022

Conditions

PharmacokineticsBioequivalence

Keywords

sumatriptanInjectionsSubcutaneous

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

A

EXPERIMENTAL

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

Device: Sumatriptan (via Intraject System)

B

EXPERIMENTAL

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

Device: Sumatriptan (via Intraject System)

C

EXPERIMENTAL

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

Device: Sumatriptan (via Intraject System)

D

EXPERIMENTAL

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

Device: Sumatriptan (via Intraject System)

E

EXPERIMENTAL

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

Device: Sumatriptan (via Intraject System)

F

EXPERIMENTAL

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

Device: Sumatriptan (via Intraject System)

Interventions

Sumatriptan (via Intraject System)DEVICE

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

ABCDEF

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance, Inc

Dallas, Texas, 75247, United States

Location

Study Officials

  • Patricia Chandler, MD

    Covance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2008

First Posted

February 13, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2006

Last Updated

November 10, 2022

Record last verified: 2009-11

Locations

US(1)