An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate)
An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate) Injection 4mg Administered Using the IMITREX STATdose System® and a TREXIMA Tablet Followed by IMI
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Washington
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Tacoma, Washington, United States, 98418
- GSK Investigational Site
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adult males and females between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests.
- Female subjects of non-childbearing potential
- Any subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
- BMI: 20-30 kg/m2, inclusive.
- Subject is willing and able to provide written informed consent.
Exclusion Criteria:
- Subjects who suffer from migraine attacks.
- Subject has confirmed or suspected ischemic heart disease; angina pectoris, history of myocardial infarction, documented silent ischemia, Prinzmetal's angina-coronary vasospasm, signs, or symptoms consistent with any of the above.
- Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's syndrome.
- Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks.
- Subject has a history of congenital heart disease.
- Subject has hypertension at screening.
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
- Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- History of impaired hepatic or renal function.
- Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort.
- Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication.
Note: Excluded from this list are: acetaminophen at doses of less than or equal to 2 grams per day and contraceptives.
- Subject has a hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist.
- Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
- Subject has a history of gastric bypass or stapling surgery.
- Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
- Subject has a history of inflammatory bowel disease.
- Treatment with an investigational drug within 30 preceding the first dose of study medication.
- Positive serum beta-human chorionic gonadotropin test -females.
- Pregnant, actively trying to become pregnant or breast-feeding.
- Subjects with a history of drug or alcohol abuse.
- History of regular alcohol consumption exceeding 7 drinks per week for females or 14 drinks per week for men within 6 months of screening.
- Positive urine drug screen including alcohol at screening.
- Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication.
- Subjects who smoke more than 10 cigarettes per day.
- History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: TREXIMA tablet followed by IMITREX injection (4mg)
TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System®
|
sumatriptan succinate / naproxen sodium tablet
sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System®
|
|
Experimental: TREXIMA tablet followed by IMITREX injection (6mg)
TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System®
|
sumatriptan succinate / naproxen sodium tablet
sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System®
|
|
Active Comparator: IMITREX tablet (100mg)
IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet
|
IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The maximum plasma concentration (Cmax) after the second dose and total exposure (measured by AUC(0-∞) calculated as pooled exposure from both the initial and second dose).
Time Frame: ten weeks
|
ten weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence and severity of adverse events, blood pressure, pulse, ECGs and clinical laboratory tests.
Time Frame: ten weeks
|
ten weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Vasoconstrictor Agents
- Sumatriptan
Other Study ID Numbers
Other Study ID Numbers
- 103629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Dataset Specification
Information identifier: 103629Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 103629Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 103629Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 103629Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 103629Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 103629Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 103629Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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