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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: All Participants | Experimental | Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | MK-8527 capsule taken by mouth |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| Tmax of EE alone and with MK-8527 | Up to ~72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with ≥1 adverse event (AE) | Up to ~28 days | |
| Percentage of participants discontinuing from study therapy due to AE | Up to ~28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS-MRA, LLC-Early Phase (Site 0001) | South Miami | Florida | 33143 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
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| LNG/EE |
| Drug |
LNG/EE combination tablet taken by mouth. |
|
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |