CompletedPhase 1

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

United States37 participantsStarted 2020-08-19

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Exclusion criteria

✕. Known adverse reaction to any of the study products (ever)
✕. Non- therapeutic injection drug use in the 12 months prior to Screening
✕. Surgical procedure involving the pelvis in the 60 days prior to enrollment (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear)
✕. Participation in a drug, spermicide and/or microbicide study in the 30 days prior to enrollment
✕. Currently pregnant or pregnancy within 42 days prior to enrollment
✕. Currently lactating
✕. Use of a diaphragm, NuvaRing®, or spermicide for contraception

What they're measuring

Number of Participants With Grade 2 or Higher Adverse Events

Timeframe: Through study completion, approximately 28 days

Trial details

NCT IDNCT04319718

SponsorHillier, Sharon, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-25

Results submitted2023-01-03

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