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delivery of sumatriptan

Phase 1

Migraine Disorders | Small Molecules | Neurology |Sorrento Therapeutics, Inc.|Trials Updated: Aug 10, 2022

delivery of sumatriptan target and mechanism

ModalitySmall Molecules

Also known as Transdermal delivery of sumatriptan succinate

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

delivery of sumatriptan clinical trials

delivery of sumatriptan · 1 trial · 1 indication

Phase 1 1
NCT03229798Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)Migraine Disorders
COMPLETED19 Analytics
PHASE1COMPLETED
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)
Migraine Disorders
NCT0322979819
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Study Endpoints

Primary Endpoints

PK Cmax
48 hours after dosing begins

Pharmacokinetic profile with Cmax (maximum concentration) of drug in blood, ng/mL

PK AUC
48 hours after dosing begins

Pharmacokinetic profile AUC (area under the curve) of drug in blood, ng-hr/mL

Secondary Endpoints

Dermatological skin response (Draize scale)
From Predose to 168 hours after device application
Pain of application and wear (VAS scale)
Upon application and after wear
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sumatriptan Succinate Oral TabletACTIVE_COMPARATOR100 mg oral tablet commercial Imitrex sumatriptan succinate tablet
Sofusa Profile #1EXPERIMENTALCombination device for transdermal delivery of sumatriptan succinate Current approved dose (SC)
Sofusa Dose Profile #2EXPERIMENTALCombination device for transdermal delivery of sumatriptan succinate- adjust dose and flow rate to achieve PK profile based on results from Sofusa Dose Profile #1
Sofusa Dose Profile #3EXPERIMENTALCombination device for transdermal delivery of sumatriptan succinate- adjust dose and flow rate to achieve PK profile based on results from Sofusa Dose Profile #2
Sofusa Dose Profile #4EXPERIMENTALCombination device for transdermal delivery of sumatriptan succinate- adjust dose and flow rate to achieve PK profile based on results from Sofusa Dose Profile #3
Sofusa Dose Profile #5EXPERIMENTALCombination device for transdermal delivery of sumatriptan succinate- adjust dose and flow rate to achieve PK profile based on results from prior Sofusa Dose Profile #2-4

Interventions

NameTypeDescription
Sumatriptan Succinate Oral TabletDRUGSumatriptan succinate commercial Imitrex 100 mg tablet
Transdermal delivery of sumatriptan succinateCOMBINATION_PRODUCTSumatriptan succinate transdermal drug delivery system
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Able to give voluntary written informed consent (personally signed and dated) and HIPPA Authorization prior to any study related procedures. 2. Available to participate for the entire study period. 3. Be a male or female person between 18 and 55 years (inclusive) of age. 4. H...

Countries:United States
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