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COMPLETEDPHASE1

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

An Open-Label Phase 1 Study to Establish the Pharmacokinetics and Safety of Sumatriptan Succinate Administered Via the Sofusa™ DoseConnect™ System at Escalating Doses Compared to Oral Imitrex® Single 100 mg Dose in Healthy Subjects

NCT03229798•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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. Healthy as determined by the investigator based on a medical evaluation including history, physical examination, electrocardiogram (ECG), and laboratory tests.
•5. Have systolic blood pressure (sitting) of \< 140 mmHg and diastolic blood pressure of \< 90 mmHg after 5 minutes of rest. Minor excursions in blood pressure outside of this range may be acceptable if determined not to be clinically significant by the study physician or medical monitor.
•6. Have resting pulse rate (sitting) within normal range of 60-100 bpm. Minor excursions in resting pulse outside of this range may be acceptable if determined not to be clinically significant by the study physician or the medical monitor.
•7. Females must be either postmenopausal for at least 1 year, surgically sterile (bilateral oophorectomy, tubal ligation, tubal occlusion, hysterectomy), or using adequate contraception from screening until 90 days after completion of study participation. Adequate contraception is defined as true abstinence, a vasectomized partner, or one of the following in combination with a diaphragm, cervical cap, or a condom:
•* Hormonal contraceptives (oral, implant, patch, injection)
•* Intrauterine device
•Males must use adequate contraception and must not donate sperm from first admission to the clinical research center until 90 days after completion of study participation. Adequate contraception is defined as true abstinence, vasectomy, a partner who is surgically sterile (bilateral oophorectomy, tubal ligation, tubal occlusion, hysterectomy), or one of the following in combination with a diaphragm, cervical cap, or a condom:
+4 more criteria

Exclusion Criteria

•1. Women who are pregnant or lactating.
•2. Current use or has used tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) 30 days prior to investigational product administration. A cotinine test (with a cut-off of 200 mg) will be performed at screening and admission to the study center.
•3. Recent history (i.e. within 2 years) of alcohol abuse, illicit drug use, or significant mental illness.
•4. Positive screen for substances of abuse.
•5. A positive screening result for human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody (anti-HCV).
•6. Any disease or condition (medical or surgical) that might compromise a major body system (e.g. cardiovascular, respiratory, etc.) or conditions that may interfere with the absorption, distribution, metabolism, or excretion of the study medication.
•7. Any bleeding disorders or use of anticoagulants.
•8. Any conditions (e.g. diabetes, edema, scleroderma) or receiving medications (e.g. steroids, antibiotics) that alter skin integrity and/or healing. Any known condition or receiving medications causing hypo/hyperpigmentation or photosensitivity.
•9. Presence or history of hypertension or other cardiovascular abnormalities such as, but not limited to, myocardial infarction, heart failure, arrhythmia, stroke, or peripheral vascular disease or any other cardiovascular disease that requires the subject to wear a pacemaker.
•10. Use of a drug therapy known to induce or inhibit hepatic drug metabolism within 30 days prior to the Treatment visit for dosing.
+14 more criteria

Locations (1)

Carolina Phase 1 Research

Raleigh, North Carolina, United States

Key Dates

Start Date

January 17, 2018

Primary Completion Date

March 28, 2018

Completion Date

March 28, 2018

Last Updated

August 10, 2022

Enrollment

ACTUAL participants

Conditions

Migraine Disorders

Interventions

Sumatriptan Succinate Oral Tablet

DRUG

Transdermal delivery of sumatriptan succinate

COMBINATION_PRODUCT

Mind Body Balance for Pediatric Migraine

NCT04715685

HeadacheHeadache Disorders+6 more

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RECRUITING

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

NCT05570149

Migraine Disorders

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RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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