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

Merck Sharp & Dohme LLC14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

Interventions

MK-8527DRUG

MK-8527 capsule taken by mouth

LNG/EEDRUG

LNG/EE combination tablet taken by mouth.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

QPS-MRA, LLC-Early Phase (Site 0001)

South Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: Up to ~96 hours postdose

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

Time frame: Up to ~96 hours postdose

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

Time frame: Up to ~96 hours postdose

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

Time frame: Up to ~96 hours postdose

AUC0-∞ of EE alone and with MK-8527

Time frame: Up to ~72 hours postdose

Tmax of EE alone and with MK-8527

Time frame: Up to ~72 hours postdose

Secondary Outcomes

Percentage of participants with ≥1 adverse event (AE)

Time frame: Up to ~28 days

Percentage of participants discontinuing from study therapy due to AE

Time frame: Up to ~28 days

Data from ClinicalTrials.gov

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