CompletedPhase 1

A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)

United States14 participantsStarted 2023-08-14

Plain-language summary

This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * is in good overall health * assigned female at birth Exclusion Criteria: * has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years * has a history of cancer (malignancy)

What they're measuring

Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

Maximum plasma concentration (Cmax) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

Time to Cmax (Tmax) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

Apparent half-life (t½) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

AUC0-∞ of EE alone and with MK-8527

Timeframe: Up to ~72 hours postdose

Tmax of EE alone and with MK-8527

Timeframe: Up to ~72 hours postdose

Trial details

NCT IDNCT06783192

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-11

View on ClinicalTrials.gov More Human Immunodeficiency Virus (HIV) trials

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

Maximum plasma concentration (Cmax) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

Time to Cmax (Tmax) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

Apparent half-life (t½) of LNG alone and with MK-8527

Timeframe: Up to ~96 hours postdose

AUC0-∞ of EE alone and with MK-8527

Timeframe: Up to ~72 hours postdose

Tmax of EE alone and with MK-8527

Timeframe: Up to ~72 hours postdose