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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 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. 

Prevention Option(s)
Microbicides
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Active 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 Delivery
Film
Products
MK-2048
ARMs
Experimental
Description
Active 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 Delivery
Film
Products
MK-2048
ARMs
Experimental
Trial Sponsors
NIAID (STUDY19100120)
August 2020
December 2021
Enrollment
48
18
Years
45
Population
Women
Sites

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania
United States of America