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

NCT03229798 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: REC-0000330, Ver 1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• PK Cmax

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

  48 hours after dosing begins

• PK AUC

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

  48 hours after dosing begins

Secondary Outcomes (2)

• 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

Study Arms (6)

Sumatriptan Succinate Oral Tablet

ACTIVE COMPARATOR

100 mg oral tablet commercial Imitrex sumatriptan succinate tablet

Drug: Sumatriptan Succinate Oral Tablet

Sofusa Profile #1

EXPERIMENTAL

Combination device for transdermal delivery of sumatriptan succinate Current approved dose (SC)

Combination Product: Transdermal delivery of sumatriptan succinate

Sofusa Dose Profile #2

EXPERIMENTAL

Combination device for transdermal delivery of sumatriptan succinate- adjust dose and flow rate to achieve PK profile based on results from Sofusa Dose Profile #1

Combination Product: Transdermal delivery of sumatriptan succinate

Sofusa Dose Profile #3

EXPERIMENTAL

Combination device for transdermal delivery of sumatriptan succinate- adjust dose and flow rate to achieve PK profile based on results from Sofusa Dose Profile #2

Combination Product: Transdermal delivery of sumatriptan succinate

Sofusa Dose Profile #4

EXPERIMENTAL

Combination device for transdermal delivery of sumatriptan succinate- adjust dose and flow rate to achieve PK profile based on results from Sofusa Dose Profile #3

Combination Product: Transdermal delivery of sumatriptan succinate

Sofusa Dose Profile #5

EXPERIMENTAL

Combination 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

Combination Product: Transdermal delivery of sumatriptan succinate

Interventions

Sumatriptan Succinate Oral Tablet DRUG

Sumatriptan succinate commercial Imitrex 100 mg tablet

Sumatriptan Succinate Oral Tablet

Transdermal delivery of sumatriptan succinate COMBINATION_PRODUCT

Sumatriptan succinate transdermal drug delivery system

Also known as: Sofusa DoseDisc, Sofusa DoseConnect, KC5010

Sofusa Dose Profile #2; Sofusa Dose Profile #3; Sofusa Dose Profile #4; Sofusa Dose Profile #5; Sofusa Profile #1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to give voluntary written informed consent (personally signed and dated) and HIPPA Authorization prior to any study related procedures.
• Available to participate for the entire study period.
• Be a male or female person between 18 and 55 years (inclusive) of age.
• Healthy as determined by the investigator based on a medical evaluation including history, physical examination, electrocardiogram (ECG), and laboratory tests.
• 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.
• 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.
• 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:
• Hormonal contraceptives (oral, implant, patch, injection)
• Intrauterine device
• Have a body weight above 50 kg and below 90 kg (inclusive).
• Be able to communicate effectively with the study personnel and understand and comply with all study requirements.

You may not qualify if:

• Women who are pregnant or lactating.
• 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.
• Recent history (i.e. within 2 years) of alcohol abuse, illicit drug use, or significant mental illness.
• Positive screen for substances of abuse.
• A positive screening result for human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody (anti-HCV).
• 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.
• Any bleeding disorders or use of anticoagulants.
• 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.
• 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.
• Use of a drug therapy known to induce or inhibit hepatic drug metabolism within 30 days prior to the Treatment visit for dosing.
• Patient has received a live attenuated vaccine within the 4 weeks prior to treatment or plans to receive one during the study.
• Febrile illness within 7 days of Treatment visit for dosing.
• Has a positive history or known sensitivity to sumatriptan or other triptans.
• Any history of sensitivity to methylene blue, fluorescein or calcein, or other similar dye product.
• Subjects who have used ergotamine-containing or ergot-type medications (like dihydrogergotamine or methysergide) within the past week. The Imitrex® label specifies that these medication are contraindicated within 24 hours of use.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead
• Kimberly-Clark Corporation: collaborator

Study Sites (1)

Carolina Phase 1 Research

Raleigh, North Carolina, 27612, United States

Location

Related Publications (3)

• Kam KR, Walsh LA, Bock SM, Koval M, Fischer KE, Ross RF, Desai TA. Nanostructure-mediated transport of biologics across epithelial tissue: enhancing permeability via nanotopography. Nano Lett. 2013 Jan 9;13(1):164-71. doi: 10.1021/nl3037799. Epub 2012 Dec 24.

  PMID: 23186530 BACKGROUND

• Walsh L, Ryu J, Bock S, Koval M, Mauro T, Ross R, Desai T. Nanotopography facilitates in vivo transdermal delivery of high molecular weight therapeutics through an integrin-dependent mechanism. Nano Lett. 2015 Apr 8;15(4):2434-41. doi: 10.1021/nl504829f. Epub 2015 Mar 27.

  PMID: 25790174 BACKGROUND

• Owen K, Hartley K, Tucker ML, Parkinson MM, Tweats DJ, Jackson MR. The preclinical toxicological evaluation of sumatriptan. Hum Exp Toxicol. 1995 Dec;14(12):959-73. doi: 10.1177/096032719501401205.

  PMID: 8962747 BACKGROUND

Related Links

• Imitrex® oral prescribing information (November 2013)

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wayne L Harper, MD

  Carolina Phase I Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 26, 2017
• Study Start: January 17, 2018
• Primary Completion: March 28, 2018
• Study Completion: March 28, 2018
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

US (1)