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 range

18 Years – 70 Years

Sex

FEMALE

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 70 Years

Sex

FEMALE

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