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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: HIV Pre-Exposure Prophylaxis; Human Immunodeficiency Virus (HIV)

Treatments: Drug: LNG/EE; Drug: MK-8527

Study type: Interventional

Funder types: Industry

Identifiers

NCT06783192

8527-006

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Arm 1: All Participants

Experimental group

Description:

Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527.

Treatment:

Drug: MK-8527

Drug: LNG/EE