Pharmacokinetics Clinical Trial
Official title:
Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT)
An open-label, randomized, 3-arm study in 162 healthy adult subjects with the following primary objective: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.
This study 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.162 subjects will be enrolled (54 subjects per study drug formulation arm) in order to achieve a minimum of 150 completers (50 completers in each arm).There will be an adequate representation of male and female subjects, subjects of all ages (including a sufficient number of elderly subjects), and subjects of different races. All 162 subjects will randomized at Day -1 and assigned to a treatment arm before study drug application on Day 1. Treatment: Approximately 2 mg of a sunscreen formulation (approximately 0.12 mg BEMT) per 1 cm2 of body surface area will be applied topically 4 times per study day for 4 days (every 2 hours for 6 hours) to at least 75% of the body surface area. Subjects will be randomly assigned to 1 of 3 treatment groups within each subgroup; Thus each subject will receive 1 of the sunscreen formulations. Treatment groups: Treatment Group B: 54 subjects; Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers; SU-E-101413-85: Sunscreen oil formulation with 10% ethanol Treatment Group C: 54 subjects; Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers, SU-E-101413-87: oil-in-water (O/W) formulation Treatment Croup D: 54 subjects: Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers, SU-E-101413-89: water-in-oil (W/O) formulation Dosing will between 07:00 and 10:00 hours followed by 3 more applications at 2, 4, and 6 hours after the 1st application each day. Blood samples collected from before the 1st application through 96 hours after the 1st application. The following noncompartmental PK parameters will be calculated for each subject using the plasma BEMT concentration-time data (data permitting): - Cmax: Maximum observed concentration; computed for Overall, Day 1, and Day 4 - Tmax: Time of Cmax; computed for Overall, Day 1, and Day 4 - C2h: The concentration at 2 hours after the 4th daily study drug application; computed for Days 1, 2, 3, and 4 - Ctrough: The concentration at the end of the study day; computed for Days 1, 2, 3, and 4 at 23.5, 47.5, 71.5, and 96 hours, respectively - AUC: Area under the concentration-time curve from before the first daily dose to the last measurable concentration in the time interval; computed for Overall, Day 1, and Day 4 - λz: Apparent elimination rate constant, computed from all relevant concentration data following the last study drug application on Day 4 - t1/2: Terminal elimination half-life, computed from λz With the time intervals for Overall and Days 1, 2, 3, and 4 defined as: - Overall = 0 to 264 hours - Day 1 = 0 to 23.5 hours - Day 2 = 23.5 to 47.5 hours - Day 3 = 47.5 to 71.5 hours - Day 4 = 71.5 to 96 hours Note: If all concentrations for a subject are below the limit of quantitation (BLQ), then only the C2h and Ctrough parameters will be reported for that subject. . ;
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