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This is a pharmacokinetic study

Phase 1

Migraine Disorders | Small molecule | Neurology |GSK plc|Last Updated: Jun 19, 2017

Target and mechanism

ModalitySmall molecule

Also known as This is a pharmacokinetic study (Treximet)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

This is a pharmacokinetic study · 1 trial · 1 indication

Phase 1 1
NCT00989625A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.Migraine Disorders
COMPLETED50 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.
Migraine Disorders
NCT0098962550
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Study Endpoints

Primary Endpoints

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 Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
10mg Sumatriptan/60mg NaproxenACTIVE_COMPARATORThere 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.
30mg Sumatriptan/180mg NaproxenACTIVE_COMPARATORThere 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.
85mg Sumatriptan/500mg NaproxenACTIVE_COMPARATORThere 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.

Interventions

NameTypeDescription
This is a pharmacokinetic study (Treximet)DRUGThis is a pharmacokinetic study to collect PK samples from subject after single dose.
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Eligibility Criteria

Age Range12 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 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 m...

Countries:United States
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