Irritation and Sensitization Study of d-Amphetamine Transdermal System

NCT04094025 | Completed Phase 1 FDA Drug

• 1 other identifier: N25-018
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cumulative Irritation and Sensitization

Outcome Measures

Primary Outcomes (2)

• Sensitization

  Number of participants with sensitization potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults

  21 days

• Irritation

  Number of participants with skin irritation potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults

  21 days

Study Arms (1)

dATS patch

EXPERIMENTAL

dATS, placebo and saline will be administered simultaneously

Drug: dATS

Interventions

dATS DRUG

d-Amphetamine Transdermal System

dATS patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Noven Therapeutics: lead

Study Sites (1)

Noven Pharmaceuticals

Jersey City, New Jersey, 07310, United States

Location

Study Officials

• George Harb, MD

  Noven Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 18, 2019
• Study Start: December 2, 2019
• Primary Completion: May 16, 2020
• Study Completion: May 16, 2020
• Last Updated: August 24, 2020

Record last verified: 2019-12

Locations

US (1)