Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Plasma PK assessment under MUsT Conditions
研究概览
简要总结
This will be a single clinical study conducted in 2 parts (Part 1: pilot study and Part 2: pivotal study).
Part 1 is an open-label, 1-arm study in 14 healthy adult subjects with the following primary objectives:
- Primary: To explore whether the active component, bemotrizinol (BEMT), is absorbed from a high-penetrating sunscreen formulation including 6% BEMT into the systemic circulation when applied under maximal-use conditions.
- Secondary: To obtain information needed for a successful pivotal study such as preliminary pharmacokinetic (PK) data, validation of study and analytical procedures, and the number of subjects needed.
Part 2 is an open-label, randomized, 3-arm study in 42 healthy adult subjects with the following objective:
• Primary: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.
详细描述
This will be a single clinical study conducted in 2 parts (Part 1: pilot study and Part 2: pivotal study). The duration of study participation will be approximately 42 days for Part 1, including a 30-day screening period, a 4-day treatment period (Days 1-4), and subjects leaving the clinical research unit (CRU) on the morning of Day 5. Subjects will then return to the CRU for follow-up visits on Days 8 and 12. On Day 12, End-of-Study activities will be completed. For Part 2, the duration of participation will be approximately the same, 42 days, and may be adjusted based on the results of Part 1.
Part 1 is an open-label, 1-arm pilot study to evaluate the effects of multiple applications of a topical sunscreen formulation in healthy adult subjects. It will include 14 subjects (7 male and 7 female) that will be admitted to the CRU on Day -1.
On the morning of Days 1 through 4, subjects will receive a topical application of the study drug between 07:00 and 10:00 hours followed by 3 more applications each day at 2, 4, and 6 hours after the first application, resulting in study drug application at 0, 2, 4, 6, 24, 26, 28, 30, 48, 50, 52, 54, 72, 74, 76, and 78 hours relative to the first application. The weight of study drug will be measured and recorded before and after dosing for each subject and each dose will be applied by a qualified person from the CRU.
Blood samples will be collected for the determination of plasma concentrations of BEMT from before the first topical application of study drug to 264 hours after the first study drug application.
Part 2 is an open-label, randomized, 3-arm pivotal study to evaluate the pharmacokinetics of BEMT after multiple applications of a topical sunscreen formulation in healthy adult subjects and may be modified based on observations from Part 1 and the Food and Drug Administration (FDA) revision. Part 2 will include 14 subjects (7 male and 7 female) in each arm. At least 3 formulations will be selected based on the plasma exposure data from the pilot study (Part 1), the in vitro permeation testing (IVPT) results, and the market survey for BEMT-containing formulations. All 42 subjects will be admitted to the CRU on Day -1 and randomly assigned to a treatment arm before study drug application on Day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all of the following inclusion criteria will be eligible to participate in the study:
- •Subject signs an IRB-approved written informed consent form (ICF) and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization) before any study-related procedures are performed.
- •Subject is a healthy man or woman, 18 to 75 years of age, inclusive, who has a body mass index of 18.5 to 29.9 kg/m2, inclusive, at Screening.
- •Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening or, if abnormal, the abnormality is not considered clinically significant (as determined and documented by the investigator or designee).
- •Subject has a negative test result for alcohol and drugs of abuse at Screening and Check-in (Day -1).
- •Female subject is surgically sterile (hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation) or has a negative serum pregnancy test result before entry into the study and practices an adequate method of birth control (e.g., oral or parenteral contraceptives, hormonal or nonhormonal intrauterine device, barrier, abstinence) during the study and until 90 days after the last application of study drug.
- •Male subject agrees to refrain from sexual activity with female partners unless an acceptable method of birth control is used by both partners. Male subject is surgically sterile or agrees to use barrier contraception (condom with spermicide), and refrain from sperm donation, from the first application of study drug until 90 days after the last application of study drug.
- •Subject has a negative SARS-CoV-2 test result (polymerase chain reaction [PCR] method).
- •Subject is highly likely (as determined by the investigator) to comply with the protocol-defined procedures and to complete the study.
排除标准
- •Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
- •Subject who participated in Part 1 of the present maximum usage trial (MUsT).
- •Subject has broken, irritated, or unhealed skin.
- •Subject has an active sunburn.
- •Subject has used a tanning bed in the previous 4 weeks.
- •Subject has known skin or autoimmune disease(s).
- •Subject is anemic or has any chronic condition(s) that may impact blood sample collection.
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study or during the 30 days after study drug administration. All female subjects will undergo a serum pregnancy test at Screening, on Day -1, and before discharge from the CRU.
- •Subject has any underlying disease or surgical or medical condition (e.g., cancer, human immunodeficiency virus [HIV], severe hepatic or renal impairment) that could put the subject at risk or would normally prevent participation in a clinical study.
- •Subject has known or suspected allergies or sensitivities to any components of the sunscreen formulation.
- •Subject has clinical laboratory test results (hematology and serum chemistry) at Screening that are outside the reference ranges provided by the clinical laboratory and considered clinically significant by the investigator.
- •Subject has used alcohol-, caffeine-, or xanthine-containing products, Seville oranges (sour), grapefruit, or grapefruit juice, within 72 hours before first study drug application.
- •Subject has a positive test result at Screening for HIV type 1 or 2 antibody, hepatitis C virus antibodies, or hepatitis B surface antigen.
- •Subject is unable or unwilling to undergo multiple venipunctures for blood sample collection because of poor tolerability or poor venous access.
- •Subject has used any product(s) containing bis-ethylhexyloxyphenol methoxyphenyl triazine (BEMT), such as sunscreen products, hand or body moisturizing lotion, makeup or foundation, hair care product, lip balm, or lipstick within 14 days before Check in (Day -1) and at any time before End-of-Study procedures.
- •Subject is unable or unwilling to tolerate the scent of sunscreen and the body coverage with sunscreen (i.e., oily appearance and sensation of sunscreen) for the duration of the treatment period.
研究组 & 干预措施
Part 1, one-arm open label pilot study
Part 1 is an open label, 1-arm pilot study to evaluate the systemic absorption and effects of multiple applications of a market-image topical sunscreen formulation containing BEMT (6%) under maximum use conditions in healthy adult subjects.
干预措施: Bemotrizinol (Drug)
结局指标
主要结局
Plasma PK assessment under MUsT Conditions
时间窗: On the morning of Days 1 through 4, subjects will receive a topical application of the study drug between 07:00 and 10:00 hours followed by 3 more applications each day at 2, 4, and 6 hours after the first application, resulting in study drug application
• To explore whether the active component, bemotrizinol (BEMT), is absorbed from a high-penetrating sunscreen formulation into the systemic circulation when applied under maximal-use conditions.
次要结局
未报告次要终点