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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2023-10-11

Brief Summary

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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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Detailed Description

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Conditions

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Human Immunodeficiency Virus (HIV) HIV Pre-Exposure Prophylaxis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1: All Participants

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

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

MK-8527 capsule taken by mouth

LNG/EE

Intervention Type DRUG

LNG/EE combination tablet taken by mouth.

Interventions

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MK-8527

MK-8527 capsule taken by mouth

Intervention Type DRUG

LNG/EE

LNG/EE combination tablet taken by mouth.

Intervention Type DRUG

Other Intervention Names

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levonorgestrel/ethinyl estradiol

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes