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)

NCT00875784 | Completed Phase 1

• 1 other identifier: 103629
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Disorders

Keywords

Sumatriptan exposure

Outcome Measures

Primary Outcomes (1)

• 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).

  ten weeks

Secondary Outcomes (1)

• Incidence and severity of adverse events, blood pressure, pulse, ECGs and clinical laboratory tests.

  ten weeks

Study Arms (3)

TREXIMA tablet followed by IMITREX injection (4mg)

EXPERIMENTAL

TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System®

Drug: TREXIMA™; Drug: IMITREX® (4mg)

TREXIMA tablet followed by IMITREX injection (6mg)

EXPERIMENTAL

TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System®

Drug: TREXIMA™; Drug: IMITREX® (6mg)

IMITREX tablet (100mg)

ACTIVE COMPARATOR

IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet

Drug: IMITREX Tablet 100mg

Interventions

TREXIMA™ DRUG

sumatriptan succinate / naproxen sodium tablet

TREXIMA tablet followed by IMITREX injection (4mg); TREXIMA tablet followed by IMITREX injection (6mg)

IMITREX® (4mg) DRUG

sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System®

TREXIMA tablet followed by IMITREX injection (4mg)

IMITREX® (6mg) DRUG

sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System®

TREXIMA tablet followed by IMITREX injection (6mg)

IMITREX Tablet 100mg DRUG

IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet

IMITREX tablet (100mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tacoma, Washington, 98418, United States

Location

Related Publications (1)

• Berges A, Walls C, Lener SE, McDonald SA. Pharmacokinetics and tolerability of sumatriptan after single-dose administration of a fixed-dose combination tablet of sumatriptan/naproxen sodium 85/500 mg followed two hours later by subcutaneous sumatriptan 4- or 6-mg injection: a randomized, open-label, three-period crossover study in healthy volunteers. Clin Ther. 2010 Jun;32(6):1165-77. doi: 10.1016/j.clinthera.2010.06.014.

  PMID: 20637969 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 103629 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: April 3, 2009
• Study Start: May 6, 2008
• Primary Completion: June 14, 2008
• Study Completion: June 14, 2008
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)