NCT04319718

Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048

A Randomized, Double Blinded Study of the Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Hillier, Sharon, PhD · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. Forty eight women will be randomized with equal frequency to receive a single dose of a vaginal film containing MK-2048 (either the high Eudragit® or low Eudragit® formulation). The film will be inserted by a clinician on the day of enrollment. Vaginal swabs and plasma will be collected at days 0, 3, 5, 7, 10, 14 and 28 for all participants. On the day of enrollment, some participants may elect to participate in immediate post insertion sample collection (vaginal swab and plasma) at one or two time points within 6 hours of insertion. Genital biopsy samples and a rectal swab will be obtained on day 7, and cervicovaginal lavage will be collected at screening and days 14 and 28. The primary endpoint is the frequency of Grade 2 or higher adverse events. The secondary endpoints are: MK-2048 concentrations in plasma, cervical tissue homogenate, cervicovaginal lavage fluid, rectal and vaginal swab eluents; self-reported assessment of qualities of the experience with the films drawn from existing survey on microbicidal films, and general acceptability ratings drawn from market research methodology.

Conditions

• Pharmacokinetics
• Safety

Interventions

Type	Name	Description
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®)
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®)

Timeline

• Start date: 2020-08-19
• Primary completion: 2022-02-25
• Completion: 2022-10-10
• First posted: 2020-03-24
• Last updated: 2023-03-03
• Results posted: 2023-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study