AzTrials
AzTrials

Migraine DisordersPhase 1KCC-SMT-002NCT03229798

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

A Phase 1 study testing Sumatriptan Succinate Oral Tablet and Transdermal delivery of sumatriptan succinate in people with Migraine Disorders, run by Sorrento Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Migraine Disorders
What is being tested?
Sumatriptan Succinate Oral Tablet and Transdermal delivery of sumatriptan succinate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
17 Jan 2018to 28 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.
  • Diagnosed with ischemic bowel disease or severe hepatic impairment which are known contraindications to sumatriptan.
  • Concomitant therapy with the following medications which have significant drug interactions with sumatriptan: selective serotonin reuptake inhibitors (SSRIs), serotonin/norepinephrine reuptake inhibitor (SNRIs), tricyclic antidepressants, and monomine oxidase (MAO) inhibitors due to an increased risk of serotonin syndrome. Subjects receiving these medications may enroll in the study if these medications have been discontinued for 5 or more half-lives prior to the first Treatment visit.
  • Subjects who are currently taking prescription or over-the-counter medications (including vitamins and herbal preparations) that could interfere with the evaluation or the safety of the subject, as determined by the Investigator.
  • Participation in the treatment phase of a clinical study or receipt of an investigational drug or medical device within 30 days prior to the Treatment visit for dosing.
  • History of difficulty with phlebotomy procedures.
  • Donated blood (>400 mL) or blood products within 45 days prior to the Treatment visit for dosing.
  • Subjects who have skin conditions or tattoos extensive enough to cover areas where the device is to be applied.
  • Any history of skin contact sensitivity to metals, plastics or adhesives.
  • Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Carolina Phase 1 Research

    Raleigh, North Carolina, 27612

Other trials in United States

About this study

Official title: 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

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.

Being tested
Sumatriptan Succinate Oral Tablet, Transdermal delivery of sumatriptan succinate
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sumatriptan Succinate Oral TabletDrug

    Sumatriptan succinate commercial Imitrex 100 mg tablet

  • Transdermal delivery of sumatriptan succinateCombination product

    Also called Sofusa DoseDisc, Sofusa DoseConnect, KC5010

    Sumatriptan succinate transdermal drug delivery system

Study groups in NCT03229798
Study groupRoleWhat they receive
Sumatriptan Succinate Oral TabletActive comparator100 mg oral tablet commercial Imitrex sumatriptan succinate tablet
Receives: Drug: Sumatriptan Succinate Oral Tablet
Sofusa Profile #1ExperimentalCombination device for transdermal delivery of sumatriptan succinate Current approved dose (SC)
Receives: Combination Product: Transdermal delivery of sumatriptan succinate
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
Receives: Combination Product: Transdermal delivery of sumatriptan succinate
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
Receives: Combination Product: Transdermal delivery of sumatriptan succinate
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
Receives: Combination Product: Transdermal delivery of sumatriptan succinate
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
Receives: Combination Product: Transdermal delivery of sumatriptan succinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PK Cmax

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

    Measured: 48 hours after dosing begins

  2. PK AUC

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

    Measured: 48 hours after dosing begins

Secondary outcomes (2)

  1. Dermatological skin response (Draize scale)

    Skin response as measured on modified Draize scale (erythema, edema, etc.)

    Measured: From Predose to 168 hours after device application

  2. Pain of application and wear (VAS scale)

    Pain as reported on Visual Analog Scale

    Measured: Upon application and after wear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2017
  2. Study start17 Jan 2018
  3. Primary completion28 Mar 2018
  4. Study completion28 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03229798
Sponsor's protocol ID
REC-0000330, Ver 1
Acronym
KCC-SMT-002
Status last verified
Aug 2022
First submitted
20 Jul 2017
Last updated
10 Aug 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23186530

  • 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.

    PubMed 25790174

  • 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.

    PubMed 8962747

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sumatriptan Succinate Oral Tablet and Transdermal delivery of sumatriptan succinate in people with Migraine Disorders, run by Sorrento Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK Cmax (time frame: 48 hours after dosing begins). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03229798, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in