FAME103

Status:Ongoing
Phase:I
Principal Investigator(s):Katherine Bunge, MD
Objective:This is a proof of concept study to determine whether an extended-release vaginal film can deliver the drug for seven days. Two film formulations containing MK-2048 which differ by dissolution and spreadability attributes will be compared for safety and pharmacokinetic outcomes. This is a phase I randomized trial assessing the safety, acceptability, and pharmacokinetics of two formulations of MK-2048 vaginal film. While the primary objective is to evaluate the safety of the product, the overarching objective of this study is to provide proof of concept that an antiretroviral drug can be delivered in an extended-release film formulation to provide drug delivery for 7 days or more after a single application.Last updated August 5, 2022
Prevention Option(s):Microbicides
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionActive Comparator: High Eudragit MK-2048 vaginal film Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®). Combination Product: MK-2048 High Eudragit Vaginal Film 2" x 2" vaginal film containing 30 mg of MK-2048 and either 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)
Mode of DeliveryFilm
ARMsExperimental
DescriptionActive Comparator: Low Eudragit MK-2048 vaginal film Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®). Combination Product: MK-2048 Low Eudragit Vaginal Film 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)
Mode of DeliveryFilm
ARMsExperimental
Official Code: NCT04319718
Trial Sponsors: NIAID (STUDY19100120)
Start Date
End Date
August 19, 2020
August 25, 2022
Enrollment:37
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women