NCT04319718View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

August 19, 2020

Primary Completion Date

February 25, 2022

Study Completion Date

October 10, 2022

Conditions
PharmacokineticsSafety
Interventions
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®)"

Trial Locations (1)

15213

Magee-Womens Hospital of UPMC, Pittsburgh

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Hillier, Sharon, PhD

OTHER

NCT04319718 - Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 | Biotech Hunter | Biotech Hunter