Cumulative Irritation and SensitizationPhase 1dATSNCT04094025

Irritation and Sensitization Study of d-Amphetamine Transdermal System

A Phase 1 study testing dATS in people with Cumulative Irritation and Sensitization, run by Noven Therapeutics 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

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Trial summary

The study will assess skin irritation as well as sensitization for d-ATS patch in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cumulative Irritation and Sensitization
What is being tested?: dATS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 229 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2019to 16 May 2020
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject provides written informed consent prior to entering the study or undergoing any study procedures;
Healthy male and female (non-pregnant, non-lactating) 18 - 65 years of age inclusive;
Subject is considered by the Principal Investigator/Sponsor to be healthy on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory test results. Deviations or excursions considered to be non-clinically significant as per the Principal Investigator are acceptable;
Subject has a normal screening ECG; non-specific ST-T wave changes or other changes deemed by the Principal Investigator as not clinically significant are acceptable;
Female subject is (i) a woman physiologically incapable of becoming pregnant [confirmed to be post-menopausal (having amenorrhea for >12 months), has had a hysterectomy with or without bilateral oophorectomy at least 6 months prior to the Screening Visit] or (ii) a woman of childbearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and must agree to either abstain from sexual intercourse or use two forms of reliable barrier method of contraception (e.g., condom with spermicide, diaphragm, IUD, contraceptive sponge) for at least 14 days before and throughout the duration of study (from Screening Visit through the Follow-up Visit) or have used a hormonal method of contraception for at least 30 days before the study and will continue to use the same type of hormonal contraceptive during the study. Acceptable forms of birth control include (i) surgical sterilization (such as a tubal ligation), which occurred more than 3 months prior to the Screening Visit (ii) approved hormonal contraceptives (such as birth control pills, implants or injections), (iii) an intrauterine device, (iv) barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository), (v) Vasectomy in male partner, which occurred more than 3 months prior to the Screening Visit; bilateral oophorectomy may be enrolled. If the female subject agrees to use an occlusive cap/vault caps with spermicidal foam/gel/film/cream/suppository and her male partner agrees to use a condom with spermicidal foam/gel/film/cream/suppository, this would constitute as two methods of birth control;
Subject has a body mass index between 18 kg/m2 and 35 kg/m2, inclusive;
Subject has liver function tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin ≤1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);
Subject is capable of understanding and complying with the protocol and has signed the Informed Consent Form.

Who cannot join

Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;
Subject with a history or presence of clinically significant disease (glaucoma, cardiovascular, hepatic, renal, gastrointestinal, neurologic, psychiatric, dermatologic, pulmonary, hematological, musculoskeletal, genitourinary, thromboembolic, advanced arteriosclerosis, hyperthyroidism, moderate to severe hypertension, asthma, urticaria, angioedema, edema, bronchospasm or immunologic disease or any other disorder). Conditions deemed not-clinically significant according to the Principal Investigator's discretion are acceptable;
Subject with a sitting blood pressure (BP) <90/50 or >139/89 mmHg and a sitting heart rate (HR) <45 or >90 beats/min;
Subject has a clinically significant ECG finding or QTcF interval >450 msec for males and >470 msec for females;
Subject has evidence of orthostatic hypotension (decrease of >20 mmHg systolic or >10 mmHg diastolic or both at supine for 5 minutes and again after assuming an upright position for 2 minutes) accompanied by symptoms (faintness, lightheadedness, dizziness, confusion);
Subject has a history of narcotic abuse, drug abuse, and alcoholism;

Show all 26Show fewer

Subject has a clinically significant abnormal laboratory test result. Deviations considered to be non-clinically significant as per the Principal Investigator are acceptable;
Subject has a history of allergy or sensitivity to amphetamine or components in the patch;
Subject has a history or presence of significant skin disorder such as atopy, psoriasis, vitiligo, chronic cutaneous lupus erythematosus (CCLE), or conditions known to alter skin appearance (e.g., rash, infection, abnormally dry skin, abrasions), presence of tissue scar (e.g., tattoo) or excessive hair, body piercing, presence of open sores at the potential site of patch application or skin type that could, in any way, confound interpretation of the trial results (i.e., skin type VI on the Fitzpatrick scale);
Subject has a lifetime history of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the application sites;
Subject with any dermatologic diseases that might interfere with the evaluation of the test site reactions;
Subject has a history of any allergy to soaps, lotions, cosmetics, adhesives, or adhesive dressings;
Subject has a history of significant allergies (including food or drug allergies, minor seasonal allergies are allowed);
Subject with a history of a condition that would significantly influence the immune response (e.g., primary or acquired immunodeficiencies such as human immunodeficiency virus (HIV) positive or AIDS, allergic diseases such as anaphylaxis, asthma or generalized drug reaction, neoplasms such as lymphoma or leukemia, or rheumatoid arthritis);
Subject with a history of severe depression, psychoses, bipolar disorder, mania, aggression, marked anxiety, agitation, tension, seizures, Tourette's Syndrome, motor tics, glaucoma, migraines, or unexplained syncope;
Subject is on medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product (e.g., cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy) within 3 weeks prior to dosing;
Subject used any excluded over the counter medications (including herbal remedies) that would interfere with the objectives of the study or are contraindicated with the study drug for at least 7 days or 4-5 five half-lives, whichever is longer, prior to the first dose;
Subject used monoamine oxidase inhibitors within 14 days of dosing;
Subject used systemic or topical drugs and analgesics at the patch application site or antihistamines within 72 hours prior to dosing or systemic or topical corticosteroids within 3 weeks of study enrollment;
Subject with symptoms of significant acute illness at Screening or prior to dosing;
Subject with positive screen for hepatitis B and C;
Subject has been sunbathing, has used a tanning bed within 7 days of the Screening Visit or Admission, or has sunburn in the test area that could interfere with skin evaluation;
Subject who could foresee an intensive solar exposure during trial participation (UV radiation etc…) within 7 to 14 days of the Screening Visit;
Subject is a Study Investigator, Sub-Investigator, Study Coordinator or is employed by the site or the Sponsor, or is an immediate family member (e.g., spouse, parent, child or sibling, whether biological or legally adopted) of an employee of the site, participating Investigator, CRO or Sponsor;
Subject has received any investigational product or therapy within 30 days prior to study drug administration;
Any subject not able to meet study requirements in the opinion of the Principal Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Noven Pharmaceuticals
Jersey City, New Jersey, 07310

Other trials in United States

About this study

Official title: A Randomized, Evaluator-blinded Study to Evaluate Skin Irritation and Sensitization of d-Amphetamine Transdermal System in Healthy Adults

The study will assess skin irritation as well as sensitization for d-ATS patch in healthy subjects.

Read the detailed description

This is a randomized, evaluator-blinded study consisting of one (1) group. The study will assess skin irritation as well as sensitization for d-ATS patch in healthy subjects. All three (3) articles (d-ATS patch, placebo patch, and saline patch) will be applied simultaneously on the back of each subject. Healthy subjects will be enrolled to participate in two (2) phases: A Screening Phase and a Treatment Phase. The total duration of the study for each subject will be about 10 - 16 weeks. The Re-challenge Test will only be performed for subjects who experience any type of sensitization during Challenge Period.

Conditions: Cumulative Irritation and Sensitization
Being tested: dATS

What participants receive

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

dATSDrug
d-Amphetamine Transdermal System

Study groups in NCT04094025
Study group	Role	What they receive
dATS patch	Experimental	dATS, placebo and saline will be administered simultaneously Receives: Drug: dATS

What is being measured

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

Sensitization
Number of participants with sensitization potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults
Measured: 21 days
Irritation
Number of participants with skin irritation potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults
Measured: 21 days

Timeline

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

2 Dec 201916 May 2020

First posted18 Sep 2019
Study start2 Dec 2019
Primary completion16 May 2020
Study completion16 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cumulative Irritation and SensitizationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04094025
Sponsor's protocol ID: N25-018
Acronym: dATS
Status last verified: Dec 2019
First submitted: 11 Sep 2019
Last updated: 24 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Evaluator-blinded Study to Evaluate Skin Irritation and Sensitization of d-Amphetamine Transdermal System in Healthy Adults
ClinicalTrials.gov ID: NCT04094025
Acronym / sponsor ID: dATS / N25-018
Conditions: Cumulative Irritation and Sensitization
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: Noven TherapeuticsIndustry (pharma, biotech, devices)
Study start: 2 Dec 2019 (actual)
Primary completion: 16 May 2020 (actual)
Study completion: 16 May 2020 (actual)
First posted: 18 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will assess skin irritation as well as sensitization for d-ATS patch in healthy subjects.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
dATS patch	Experimental	Drug: dATSdATS, placebo and saline will be administered simultaneously

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject provides written informed consent prior to entering the study or undergoing any study procedures;
Healthy male and female (non-pregnant, non-lactating) 18 - 65 years of age inclusive;
Subject is considered by the Principal Investigator/Sponsor to be healthy on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory test results. Deviations or excursions considered to be non-clinically significant as per the Principal Investigator are acceptable;
Subject has a normal screening ECG; non-specific ST-T wave changes or other changes deemed by the Principal Investigator as not clinically significant are acceptable;
Female subject is (i) a woman physiologically incapable of becoming pregnant [confirmed to be post-menopausal (having amenorrhea for >12 months), has had a hysterectomy with or without bilateral oophorectomy at least 6 months prior to the Screening Visit] or (ii) a woman of childbearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and must agree to either abstain from sexual intercourse or use two forms of reliable barrier method of contraception (e.g., condom with spermicide, diaphragm, IUD, contraceptive sponge) for at least 14 days before and throughout the duration of study (from Screening Visit through the Follow-up Visit) or have used a hormonal method of contraception for at least 30 days before the study and will continue to use the same type of hormonal contraceptive during the study. Acceptable forms of birth control include (i) surgical sterilization (such as a tubal ligation), which occurred more than 3 months prior to the Screening Visit (ii) approved hormonal contraceptives (such as birth control pills, implants or injections), (iii) an intrauterine device, (iv) barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository), (v) Vasectomy in male partner, which occurred more than 3 months prior to the Screening Visit; bilateral oophorectomy may be enrolled. If the female subject agrees to use an occlusive cap/vault caps with spermicidal foam/gel/film/cream/suppository and her male partner agrees to use a condom with spermicidal foam/gel/film/cream/suppository, this would constitute as two methods of birth control;

Key exclusion criteria (26 listed)

Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;
Subject with a history or presence of clinically significant disease (glaucoma, cardiovascular, hepatic, renal, gastrointestinal, neurologic, psychiatric, dermatologic, pulmonary, hematological, musculoskeletal, genitourinary, thromboembolic, advanced arteriosclerosis, hyperthyroidism, moderate to severe hypertension, asthma, urticaria, angioedema, edema, bronchospasm or immunologic disease or any other disorder). Conditions deemed not-clinically significant according to the Principal Investigator's discretion are acceptable;
Subject with a sitting blood pressure (BP) <90/50 or >139/89 mmHg and a sitting heart rate (HR) <45 or >90 beats/min;
Subject has a clinically significant ECG finding or QTcF interval >450 msec for males and >470 msec for females;
Subject has evidence of orthostatic hypotension (decrease of >20 mmHg systolic or >10 mmHg diastolic or both at supine for 5 minutes and again after assuming an upright position for 2 minutes) accompanied by symptoms (faintness, lightheadedness, dizziness, confusion);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dATSd-Amphetamine Transdermal System	Drug	dATS patch

Primary outcome

Sensitization
Time frame: 21 days
Number of participants with sensitization potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults
Irritation
Time frame: 21 days
Number of participants with skin irritation potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Harb, MD study director

Noven Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dATS in people with Cumulative Irritation and Sensitization, run by Noven Therapeutics 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 8 inclusion and 26 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 24 Aug 2020. 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?

Sensitization (time frame: 21 days). 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 NCT04094025.

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 24 Aug 2020.