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Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)

NCT03229798 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-08-10

No results posted yet for this study

Summary

Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.

Conditions

  • Migraine Disorders

Interventions

DRUG

Sumatriptan Succinate Oral Tablet

Sumatriptan succinate commercial Imitrex 100 mg tablet

COMBINATION_PRODUCT

Transdermal delivery of sumatriptan succinate

Sumatriptan succinate transdermal drug delivery system

Sponsors & Collaborators

  • Kimberly-Clark Corporation

    collaborator INDUSTRY

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Wayne L Harper, MD · Carolina Phase I Research, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2018-03-28
Completion
2018-03-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03229798 on ClinicalTrials.gov