Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study

NCT04355286 | Completed Phase 1 FDA Drug

• 1 other identifier: BEMT-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Absorption; Chemicals; Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Plasma PK assessment under MUsT Conditions

  • 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.

  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

Study Arms (1)

Part 1, one-arm open label pilot study

EXPERIMENTAL

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.

Drug: Bemotrizinol

Interventions

Bemotrizinol DRUG

Market-image topical sunscreen formulation containing BEMT (6%)

Also known as: Bis-ethylhexyloxyphenol Methoxyphenyl Triazine, BEMT, PARSOL Shield, Tinosorb S, UNII-PWZ1720CBH, CAS: 187393-00-6

Part 1, one-arm open label pilot study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead
• Spaulding Clinical Research LLC: collaborator

Study Sites (1)

Spaulding Clinical Research LLC

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

bis-ethylhexyloxyphenol methoxyphenyl triazine

Study Officials

• Carlos Sanabria, MD

  Spaulding Clinical Research LLC

  PRINCIPAL INVESTIGATOR

• Rolf Schultz, PhD

  DSM Nutritional Products, LLC

  STUDY DIRECTOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: November 3, 2020
• Primary Completion: November 6, 2020
• Study Completion: November 17, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)