CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 37 enrolled
Drug / intervention
MK-2048 High Eudragit Vaginal Film +1 morecombination
Likely dose
MK-2048 High Eudragit Vaginal Film 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04319718
NCT04319718Phase 1Completed
CompareCT.gov

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

Hillier, Sharon, PhD·interventional·Posted Mar 24, 2020·Updated Mar 3, 2023

In Brief

A Phase 1 clinical trial evaluating MK-2048 High Eudragit Vaginal Film and MK-2048 Low Eudragit Vaginal Film for Pharmacokinetics and Safety. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics, Safety
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedMar 24, 2020
Enrollment StartAug 19, 2020
Primary CompletionFeb 25, 2022
Study CompletionOct 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.3 years ago

Interventions

MK-2048 High Eudragit Vaginal Filmcombination

2" x 2" vaginal film containing 30 mg of MK-2048 and either 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®)

MK-2048 Low Eudragit Vaginal Filmcombination

2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®)