A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.

NCT00989625 | Completed Phase 1 DMC

• 1 other identifier: 108504
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters will be compared between these two groups and between doses.

Conditions

Migraine Disorders

Keywords

migraine; single dose; healthy volunteer; adolescence; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To compare the pharmacokinetics of naproxen sodium and sumatriptan following the administration of the combination tablet at 3 doses (10mg sumatriptan/60mg naproxen, 30mg sumatriptan/180mg naproxen, 85mg sumatriptan/500mg naproxen) from 0 to 48 hours.

  Derived pharmacokinetic parameters including AUC(0-2), AUC(0-Inf), AUC(0-t) and Cmax for sumatriptan at each dose. Derived pharmacokinetic parameters including AUC(0-Inf), AUC(0-t) and Cmax, for naproxen at each dose from 0 to 48 hours.

Secondary Outcomes (2)

• To investigate the safety and tolerability of the combination tablet at 3 doses in adolescent migraine subjects and healthy adult subjects over 2 weeks.

  Derived PK parameters including tmax, t½, and Cl/F (0-48 hours) for sumatriptan at each dose. Derived pharmacokinetic parameters including tmax and t½ and Cl/F for naproxen sodium at each dose. Reported AEs, BP, heart rate, 12-Lead (0-48 hours).

• Report adverse events, blood pressure, heart rate and 12-Lead ECG over 2 weeks.

  These will be measured after dosing within 48 hours and 7-14 days after dosing period.

Study Arms (3)

10mg Sumatriptan/60mg Naproxen

ACTIVE COMPARATOR

There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen.

Drug: This is a pharmacokinetic study (Treximet)

30mg Sumatriptan/180mg Naproxen

ACTIVE COMPARATOR

There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen.

Drug: This is a pharmacokinetic study (Treximet)

85mg Sumatriptan/500mg Naproxen

ACTIVE COMPARATOR

There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen.

Drug: This is a pharmacokinetic study (Treximet)

Interventions

This is a pharmacokinetic study (Treximet) DRUG

This is a pharmacokinetic study to collect PK samples from subject after single dose.

10mg Sumatriptan/60mg Naproxen

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent Migraine Subjects
• Subject has history of migraine with or without aura.
• Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours.
• Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the screening visit.
• Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
• Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches).
• All subjects
• Subject must fall between following age ranges:
• Adolescent subjects between 12 and 17 years old inclusive at the screening visit and 18 years at dosing.
• Adult healthy subjects between 18 to 55 years old inclusive at the screening visit.
• Subject BMI and weight must fall between the following:
• Adolescent subject body weight less than 33.4 kg and a healthy weight using age-based BMI range 5th-85th percentile (see Appendix 4).
• Adult healthy subject BMI within the range 18-32 kg/m2 inclusive
• Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• A female subject is eligible to participate if she is of:

You may not qualify if:

• Adolescent Migraineur Subjects
• Subject has ≥15 headache days per month in total, retinal, basilar or hemiplegic migraine or secondary headaches.
• Subject is experiencing a migraine attack or has experienced a migraine attack within 24 hours of dosing.
• All subjects:
• The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• A positive test for HIV antibody.
• Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1)
• Subject has uncontrolled hypertension
• Adults: systolic \>/=140 mmHg, diastolic \>/=90mmHg
• Adolescent BP \>/= 95 percentile adjusted for age, height and gender (Appendix 4).
• Subject has a history of congenital heart disease, 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 evidence or history of any ischemic vascular diseases including:ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of the above.
• Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks, epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
• Subject has a history of impaired hepatic or renal function

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38105, United States

Location

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 108504 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Migraine Disorders

Interventions

sumatriptan-naproxen

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: October 5, 2009
• Study Start: November 4, 2008
• Primary Completion: September 10, 2009
• Study Completion: September 10, 2009
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (3)