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)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00875784
First received: March 26, 2009
Last updated: August 30, 2010
Last verified: August 2010
  Purpose

This study will evaluate the exposure of sumatriptan after administration of TREXIMA (sumatriptan 85mg/naproxen sodium 500mg) followed by a subcutaneous IMITREX injection (4mg or 6mg) 2 hours later compared to administration of a IMITREX 100mg tablet followed by a IMITREX 100mg tablet 2 hours later.


Condition Intervention Phase
Migraine With or Without Aura
Migraine Disorders
Cluster Headache
Migraine
Drug: TREXIMA™
Drug: IMITREX® (4mg)
Drug: IMITREX® (6mg)
Drug: IMITREX Tablet 100mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of adverse events, blood pressure, pulse, ECGs and clinical laboratory tests. [ Time Frame: ten weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®
Drug: TREXIMA™
sumatriptan succinate / naproxen sodium tablet
Drug: IMITREX® (4mg)
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®
Drug: TREXIMA™
sumatriptan succinate / naproxen sodium tablet
Drug: IMITREX® (6mg)
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
Drug: IMITREX Tablet 100mg
IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet

Detailed Description:

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 IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® compared with an IMITREX Tablet 100mg followed by an IMITREX Tablet 100mg.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875784

Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00875784     History of Changes
Other Study ID Numbers: 103629, GR43175 FITH
Study First Received: March 26, 2009
Last Updated: August 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Sumatriptan exposure

Additional relevant MeSH terms:
Cluster Headache
Headache
Migraine Disorders
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Naproxen
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on August 19, 2014