Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Conditions
Brief 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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tmax of EE alone and with MK-8527 | Up to ~72 hours postdose |
| Apparent half-life (t½) of LNG alone and with MK-8527 | Up to ~96 hours postdose |
| AUC0-∞ of EE alone and with MK-8527 | Up to ~72 hours postdose |
| Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527 | Up to ~96 hours postdose |
| Maximum plasma concentration (Cmax) of LNG alone and with MK-8527 | Up to ~96 hours postdose |
| Time to Cmax (Tmax) of LNG alone and with MK-8527 | Up to ~96 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants discontinuing from study therapy due to AE | Up to ~28 days |
| Percentage of participants with ≥1 adverse event (AE) | Up to ~28 days |
Countries
United States
Outcome results
None listed